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OBR Radar! In the fast-paced world of oncology, we thought that you should have a product that will help you stay ahead of the key market-moving events in your industry.

OBR Radar is a snapshot of upcoming pivotal events in the oncology industry which may impact stock prices or make headlines in the media such as FDA action dates, anticipated announcement of pivotal clinical data, and ODAC dates. Trust OBR to be your resource allowing you to look forward into the future of oncology.

2018

Date Company Product Event
June 30,2018 Vicinium™ Eleven Biotherapeutics (formerly Viventia Bio)

Topline phase 3 data is expected in the first half of 2018 for Vicinium, being developed for high-grade non-muscle invasive bladder cancer. In a phase 2 trial, Vicinium demonstrated a complete response rate of 40% at three months with no drug-related serious adverse events.

April 17,2018 Rigel Pharmaceuticals Tavalisse™ (fostamatinib disodium) The company said on June 19, 2017 that the FDA had filed its NDA for the use of Tavalisse™ (fostamatinib disodium) in patients with chronic or persistent immune thrombocytopenia (ITP). The PDUFA action date is April 17, 2018.
March 31,2018 Celltrion Inc. / Teva Pharmaceutical  CT-P10
The companies said on June 29, 2017 that the biologics license application (BLA) for CT-P10 had been accepted for filing by the FDA for standard review, with regulatory action expected during the first quarter of 2018.  CT-P10 is a proposed monoclonal antibody (mAb) biosimilar to Rituxan® (rituximab), which is used to treat patients with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), and several other non-cancer indications.
March 31,2018 Eli Lilly & Co. abemaciclib Lilly announced on July 10, 2017 that the FDA had accepted its NDA and granted a Priority Review to abemaciclib, a CDK 4 & 6 inhibitor, as a treatment for advanced breast cancer. The company is seeking approval for two indications: as a monotherapy for patients with HR+, HER2- advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease; and in combination with fulvestrant in women with HR+, HER2- advanced breast cancer who had disease progression following endocrine therapy. The submission is based on the MONARCH 1 (phase 2) and MONARCH 2 (phase 3) studies, respectively. FDA action on the application for abemaciclib is expected in Q1 2018.
February 03,2018 Amgen Xgeva® (denosumab) The company said on June 19, 2017 that the FDA had accepted the sBLA for Xgeva that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. The FDA has set a PDUFA action date of Feb. 3, 2018.

2017

Date Company Product Event
November 30,2017 Jazz Pharmaceuticals Vyxeos™ (CPX-351) Jazz said on May 31, 2017 that the FDA had accepted the NDA for Vyxeos (CPX-351), a novel injection, and granted the application a priority review as a treatment for acute myeloid leukemia (AML). The submission includes data presented at 2016 ASCO from a pivotal phase 3 study comparing the formulation with cytarabine and daunorubicin (7+3).  The study's results showed that Vyxeos reduced the risk of death by 31% compared with 7+3 for older patients with high-risk, secondary AML.
November 29,2017 Kite Pharma axicabtagene ciloleucel (also known as KTE-C19) On May 26, 2017,  Kite said that the FDA had accepted for priority review its BLA for its lead product candidate, KTE-C19, the first investigational CAR-T therapy to demonstrate positive data in aggressive non-Hodgkin Lymphoma (NHL) in the ZUMA-1 phase 2 trial.  The FDA has set a PDUFA target action date of November 29, 2017.  
November 17,2017 Bayer copanlisib
Bayer announced on May 17, 2017 that the FDA had granted Priority Review designation for the NDA for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies.
Regulatory submission is based on data from the phase 2 CHRONOS-1 study, in which copanlisib showed an objective response rate (ORR) of 59%, in addition to a manageable safety profile. Copanlisib has been granted Fast Track and Orphan Drug Designation in the U.S. for FL.  With an expedited priority review timeframe for a decision, the FDA should make a decision on whether or not to approve copanlisib by Nov. 17, 2017.
November 09,2017 Bristol-Myers Squibb Co. Sprycel® (dasatinib) Bristol-Myers Squibb said on July 10, 2017 that the FDA had accepted its sNDA to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase (CP) chronic myeloid leukemia (CML), as well as a powder for oral suspension (PFOS) formulation.  The application is under priority review with an action date of Nov. 9, 2017, and is based on results from the phase 2 CA180-226 study presented at both 2017 ASCO and the 2017 EHA Congress.
October 30,2017 Eagle Pharmaceuticals Pemetrexed Injection, 25 mg/mL The company said on Feb. 28, 2017 that the 505(b)(2) NDA for its novel Pemetrexed Injection, 25 mg/mL had been accepted for filing by the FDA and a PDUFA target date of October 30, 2017 assigned for the completion of the agency's review.  Eagle is seeking approval of its ready-to-dilute 500 mg liquid formulation of pemetrexed (25 mg/mL) for advanced nonsquamous NSCLC and mesothelioma (in combination with the chemo agent cisplatin).
October 09,2017 Mylan / Biocon MYL-1401H The FDA has accepted for review the Biologics License Application (BLA) for MYL-1401H (Mylan and Biocon), a proposed biosimilar candidate to Amgen's Neulasta (pegfilgrastim). The proposed Neulasta biosimilar is indicated for the reduction of the duration of neutropenia and the incidence of neutropenia-associated fever in patients treated with chemotherapy in certain cancer types. The FDA has set a Biosimilar User Fee Act (BsUFA) target date of Oct. 9, 2017 to make a decision on the BLA.
September 30,2017 AstraZeneca Lynparza (olaparib) tablets (300mg twice daily) The company announced on Mar. 28 that the FDA had accepted its New Drug Application (NDA) for Lynparza (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting. The FDA also granted priority review status with a PDUFA set for third quarter 2017. The NDA submission includes the phase 3 SOLO-2 trial data, showing a reduced risk of disease progression by 70% compared with placebo in germline BRCA-mutated patients. Lynparza tablets are an investigational formulation and are not FDA-approved for any use at this time.
September 30,2017 Novartis CTL019 (tisagenlecleucel-T) The company said on Mar. 29, 2017 that the FDA had accepted its BLA filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational CAR-T therapy, in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). The application is the first BLA submission by Novartis for a CAR-T. An FDA advisory committee will review the BLA for CTL019 on July 12, 2017.  The FDA action date for a decision on the treatment is late September 2017.        
September 30,2017 Pfizer Inc. Mylotarg (gemtuzumab ozogamicin) for intravenous use Seven years after being withdrawn from the market because it failed to show clinical benefit and after patients deaths in a post-marketing study, Pfizer’s drug Mylotarg has another shot at an approval by U.S. regulators. In 2000, the drug was granted an FDA accelerated approval as a monotherapy for elderly patients with relapsed acute myeloid leukemia (AML).  Pfizer biologics license application (BLA) for Mylotarg will be reviewed by an ODAC on July 11, 2017. The company is seeking approval for Mylotarg in combination with daunorubicin and cytarabine for adult patients with previously untreated, de novo acute myeloid leukemia (AML). The FDA is expected to make a final approval decision on Mylotarg in late September 2017. (See our July 11, 2017 Pfizer listing for more details.)
September 22,2017 Merck Keytruda® (pembrolizumab) A sBLA based on data from the KEYNOTE-059 study was accepted by the FDA for a priority review in May 2017 for pembrolizumab as a treatment for patients following at least 2 courses of therapy for recurrent or advanced gastric or GEJ adenocarcinoma. The agency is expected to announce a decision by September 22, 2017.
September 14,2017 Amgen ABP 215 An ODAC panel will review Amgen's ABP 215, a proposed biosimilar candidate to Genentech/Roche’s Avastin (bevacizumab), on July 13, 2017.  Avastin is indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer, HER2-negative breast cancer, glioblastoma, renal cell carcinoma and cervical cancer. The FDA’s final decision on ABP 215 is expected on Sept. 14, 2017.        
September 03,2017 Mylan N.V. MYL-1401O Mylan N.V.’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar to Roche's breast cancer drug Herceptin, is slated to be reviewed by an FDA advisory committee on July 13, 2017. The FDA’s final decision date on MYL-1401O is set for September 3, 2017.  MYL-1401O will be the first Herceptin biosimilar to win the FDA's green light if it's approved.
August 31,2017 Pfizer Inc. Besponsa® (inotuzumab ozogamicin) Besponsa received Breakthrough Therapy designation from the FDA in October 2015 for ALL.  A biologics license application (BLA) for Besponsa for the treatment of adult patients with relapsed/refractory B-cell precursor ALL was accepted for filing and granted Priority Review by the FDA in March 2017. The PDUFA goal date for an FDA decision is August 2017.
August 30,2017 Celgene Corp. / Agios Pharmaceuticals enasidenib (AG-221/CC-90007) Celgene Corp. and Agios Pharmaceuticals announced on Mar. 1, 2017 that the FDA had accepted Celgene’s New Drug Application (NDA) for enasidenib (AG-221/CC-90007) for the treatment of patients with relapsed/refractory acute myeloid leukemia (AML) with an IDH2 mutation. The NDA was granted Priority Review and assigned a PDUFA action date of Aug. 30, 2017.  Additionally, Abbott has also submitted a Premarket Approval (PMA) application to the FDA for an IDH2 assay testing patients for that mutation.    
August 27,2017 Merck and Pfizer avelumab The companies announced on Feb. 28, 2017 that the FDA had accepted for Priority Review the Biologics License Application (BLA) for the anti-PD-L1 antibody, avelumab, as a treatment for patients with metastatic urothelial carcinoma (mUC) with disease progression on or after platinum-based therapy.  U.S. regulators are also reviewing an application for avelumab as a treatment for metastatic Merkel cell carcinoma; avelumab is not approved for any indication in any market. The FDA has set a PDUFA target action date of August 27, 2017 for a decision on the mUC indication.
August 23,2017 Novartis Zykadia® (ceritinib) Novartis said that the FDA had accepted the sNDA for filing, and granted Priority Review for the expanded use of Zykadia as a first-line treatment for patients with metastatic non-small cell cancer (NSCLC) whose tumors are ALK+ as detected by an FDA-approved test.  The FDA also granted Breakthrough Therapy designation to Zykadia for the first-line treatment of patients with ALK+ metastatic NSCLC with metastases to the brain.  Given the Priority Review designation, the FDA should take action on the application within 6 months, or by Aug. 23, 2017.  
August 21,2017 Pfizer inotuzumab ozogamicin Pfizer announced on Feb. 21, 2017 that a Biologics License Application (BLA) for inotuzumab ozogamicin had been accepted for filing and granted Priority Review by the FDA. Inotuzumab ozogamicin is being evaluated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The PDUFA goal date for a decision is in August 2017.
August 14,2017 Amgen Blincyto® (blinatumomab) On Mar. 29, 2017  Amgen said that the FDA had accepted for priority review the sBLA for blinatumomab to include overall survival (OS) data from the phase 3 TOWER study. The application also includes new data supporting an indication for Ph+ relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).  Amgen said that the sBLA aims to expand Blincyto's indication for the treatment of all patients with r/r B-cell precursor ALL and supports the conversion of Blincyto's accelerated approval to full approval.  In the phase 3 TOWER study, comparing Blincyto with standard of care chemotherapy in adult patients with Ph- r/r B-cell precursor ALL, Blincyto nearly doubled median OS. The PDUFA target action date for the sBLA is Aug. 14, 2017.
August 02,2017 Bristol-Myers Squibb Opdivo® (nivolumab) Bristol-Myers Squibb announced on Apr. 4, 2017 that the FDA had accepted a sBLA for nivolumab as a treatment for patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. The application is under priority review, with an action date of August 2, 2017.
August 02,2017 Bristol-Myers Squibb Co. Opdivo® (nivolumab) injection for intravenous use The FDA approved yet another indication for Opdivo (nivolumab) on Aug. 1, 2017 as a treatment for adult and pediatric patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.  The new indication was granted under accelerated approval, which is  based on the overall response rate and duration of response as demonstrated in the phase 2 CheckMate-142 study.
August 01,2017 Celgene Corp. / Agios Pharmaceuticals Idhifa® (enasidenib) On Aug. 1, 2017 the FDA granted approved to Idhifa® (enasidenib) for adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an IDH2 mutation, as detected by an FDA approved test.  Idhifa is the first and only oral, targeted inhibitor of IDH2 ever approved.  Idhifa was approved concurrently with Abbott Labs' RealTime™ IDH2 companion diagnostic test, used to identify AML patients with IDH2 gene mutations, which is a very small subset of AML patients. Primary supporting evidence for the drug's approval application came from a single-arm trial of 199 patients with IDH2-positive relapsed/refractory AML. The FDA had previously granted enasidenib priority review and orphan drug designations.                  
July 17,2017 Puma Biotechnology Nerlynx™ (neratinib, formerly known as PB272) On July 17, 2017 U.S. regulators approved Puma's Nerlynx (neratinib), making it the first anti-HER2 treatment to be FDA-approved as extended adjuvant therapy for early-stage HER2-positive breast cancer following adjuvant Herceptin-based therapy. On May 24, 2017 an ODAC panel voted 12-4 in favor of approval based on a favorable risk-benefit profile for the therapy.  The company expects neratinib to become commercially available in September 2017.            
July 13,2017 Amgen Inc. ABP 215 During a morning session, an FDA advisory committee will review Amgen's ABP 215, a proposed biosimilar to Genentech/Roche’s Avastin (bevacizumab).  The proposed indications for the product are: (1) for the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil-based chemotherapy; (2) in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line ABP 215-containing regimen; (3) for the first-line treatment of unresectable, locally advanced, recurrent or metastatic NSCLC in combination with carboplatin and paclitaxel; (4) for the treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent; (5) for the treatment of metastatic renal cell carcinoma in combination with interferon alfa; and (6) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix. The FDA is expected to make a decision on approval by  FDA’s final decision on ABP 215 is expected to be announced by September 14, 2017. (See Sept. 14, 2017 Amgen listing for more details.)
July 13,2017 Mylan GmbH MYL-1401O During an afternoon session on Thursday, July 13, 2017, an FDA advisory committee will review Mylan's proposed biosimilar to Genentech Herceptin (trastuzumab). The proposed indications for the product are: (1) For adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer; (a) as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; (b) with docetaxel and carboplatin; or (c) as a single agent following multi-modality anthracycline based therapy; (2) in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer; (3) as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease; and (4) in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.  
July 12,2017 Novartis AG CTL019 (tisagenlecleucel-T) At an all-day meeting on Wednesday, July 12, 2017, an ODAC voted 10-0 and recommended Novartis's CAR-T therapy, CTL019, for FDA approval as a treatment for relapsed and refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) in children and young adults.  The vote was a milestone since CTL019 is the first CAR-T therapy to come before the FDA for review and stands a good chance of becoming the first cancer gene therapy to be approved by U.S. regulators ahead of similar CAR-T therapies from competitors like Kite Pharma.  The CAR-T therapy could change the standard of care for serious blood diseases like leukemia if it's approved as anticipated.  A decision on Novartis' application is expected by Sept. 29, 2017 .  (See our September 29, 2017 Novartis listing for more details.)
July 11,2017 Pfizer Inc. Mylotarg (gemtuzumab ozogamicin) for intravenous use On Tues., July 11, 2017 an Oncologic Drugs Advisory Committee  (ODAC) voted 6 - 1 to recommend Mylotarg for approval and said that combined with chemotherapy the treatment has a favorable risk:benefit profile for patients with newly-diagnosed CD33-positive AML. Pfizer is seeking approval for the drug, which was withdrawn from the market in 2010. (See September 2017 Pfizer listing for more details.)
July 07,2017 AstraZeneca Imfinzi™ (durvalumab) and tremelimumab
Initial results from the highly anticipated phase 3 MYSTIC trial, testing the combination of AstraZeneca’s two immunotherapy drugs, Imfinzi (durvalumab) and tremelimumab, in previously untreated patients with advanced NSCLC, will prove to be a make-or-break moment for the company. Analysts anticipate the data to be unveiled in late June or early July.  The goal of the study is to show that durvalumab combined with tremelimumab is more effective than chemotherapy for patients with a high level of the PD-L1 biomarker, and in a broader group of people with tumors.  A group of 1,118 patients in 17 countries are taking part in MYSTIC.  Details on how well the treatment extends the time before cancer worsens are set to be presented at a medical conference later this year, while overall survival data may not be ready until 2018.
June 30,2017 Array BioPharma binimetinib (MEK162)

The company said on Sept. 1, 2016 that the FDA had accepted its NDA for binimetinib and assigned a PDUFA target action date of June 30, 2017. The NDA submission is based on findings from the pivotal phase 3 NEMO (NRAS MELANOMA AND MEK INHIBITOR) trial in patients with NRAS-mutant melanoma. In results presented at ASCO 2016, the study met its primary endpoint of improving progression-free survival (PFS) compared with dacarbazine treatment (median PFS for the binimetinib arm was 2.8 mos. versus 1.5 mos. for the dacarbazine arm). The FDA plans to hold an advisory committee meeting (ODAC) as part of the review process. The company said it's also preparing for an Application Orientation Meeting with the FDA in September 2016, which it expects will include a discussion of the NDA package, including clinical risk/benefit.

June 30,2017 Tesaro niraparib The NDA for niraparib, an oral, once-daily PARP inhibitor, was granted priority review by the FDA for patients with recurrent ovarian cancer following response to platinum-based chemotherapy and is supported by data from the phase 3 ENGOT-OV16/NOVA trial.  The agency has established a PDUFA goal date of June 30, 2017 for a decision on the application. Niraparib is the only PARP inhibitor that has shown a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, in a phase 3 trial.    
June 26,2017 Roche / Genentech Rituxan® (rituximab) for injection Genentech said on Mar. 29 that the FDA Oncologic Drugs Advisory Committee (ODAC) had unanimously recommended the approval of subcutaneous (under the skin) rituximab for certain blood cancers, including previously untreated follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), r/r low grade or follicular lymphoma, and previously untreated and r/r chronic lymphocytic leukemia (CLL). The new co-formulation of rituximab/hyaluronidase would take only minutes to administer compared to the much longer time of an hour and a half or more required to administer intravenous Rituxan to patients. The FDA is expected to make a final decision on approval by Jun. 26, 2017.
June 15,2017 OncoGenex Pharmaceuticals Custirsen

The final survival analysis from the phase 3 ENSPIRIT trial of custirsen, in combination with docetaxel as second-line chemotherapy in patients with advanced, unresectable non-small cell lung cancer, is expected in the first half of 2017.

June 14,2017 Merck & Co. Keytruda® (pembrolizumab) The company said on Feb. 3, 2017 that the FDA had accepted for review its two marketing applications to expand Keytruda's use as both a first- and second-line treatment in advanced bladder cancer.  Merck is seeking approval in the first-line setting for pembrolizumab's use in patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing therapy, while second-line use is being sought for use in patients with disease progression on or after platinum-containing chemotherapy. Both applications have been granted a Priority Review and are based on data from the phase 2 KEYNOTE-052 trial and the phase 3 KEYNOTE-045 trial, respectively. The PDUFA date for both applications is June 14, 2017.    
May 10,2017 Merck & Co. Keytruda® (pembrolizumab) The FDA is slated to decide on May 10, 2017 whether or not to approve Merck's immunotherapy, Keytruda, in combination with chemotherapy (pemetrexed plus carboplatin) as a first-line treatment for patients with advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberrations. This is Merck's first application seeking regulatory approval of the anti-PD-1 therapy  in combination with another treatment. U.S. regulators granted the sBLA a Priority Review with a PDUFA, or target action, date of May 10, 2017.  The sBLA will be reviewed under the FDA’s Accelerated Approval program. KEYNOTE-021, Part 2, Cohort G, is the pivotal cohort forming  the basis of the submission.    
April 30,2017 Roche / Genentech Tecentriq® (atezolizumab) Roche wants to expand the label of its first cancer immunotherapy, Tecentriq, for an additional type of advanced bladder cancer. The FDA accepted Roche's supplemental Biologics License Application (sBLA) and granted priority review to Tecentriq for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are ineligible for cisplatin chemotherapy, and are either previously untreated or have disease progression at least 12 months after receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).  Atezolizumab is already approved for use in previously treated bladder cancer and in lung cancer. The submission is based on results from the Phase 2 IMvigor210 study; an approval decision is due from the FDA by Apr. 30, 2017.
April 29,2017 ARIAD Pharmaceuticals brigatinib

ARIAD announced on Oct. 31, 2016 that the FDA had accepted for review the company's NDA for its investigational oral ALK inhibitor, brigatinib, in patients with metastatic ALK+ non-small cell lung cancer (NSCLC) who have progressed on crizotinib. The agency assigned a Priority Review to ARIAD's marketing application and set a PDUFA action date of April 29, 2017 for an approval decision .

April 29,2017 Takeda Pharmaceuticals The FDA is expected to decide on the approval status of brigatinib, which is under review for ALK+ non-small cell lung cancer (NSCLC). A response is expected from the agency by Apr. 29, 2017. Takeda acquired the investigational oral ALK inhibitor following its Feb. 2017 acquisition of ARIAD.
March 31,2017 AstraZeneca Tagrisso® (osimertinib) On Mar. 31, 2017 the FDA granted full approval for Tagrisso® (osimertinib) 80mg once-daily tablets for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed on or after first-generation EGFR-TKI therapy. Tagrisso is the first and only approved medicine in the US for the indication.  The company said that the conversion from accelerated (granted in 2015) to full approval confirmed the potential of Tagrisso to become the standard of care in the US for this patient population. Full approval is based on the phase 3 AURA3 trial demonstrating significant improvement in progression-free survival with Tagrisso as compared to chemotherapy.          
March 15,2017 Merck & Co. Keytruda® (pembrolizumab) On March 15, 2017, the FDA will decide whether or not to approve Keytruda as a treatment for patients with refractory classical Hodgkin lymphoma (cHL) or for patients with cHL who have relapsed after three or more prior lines of therapy.  The FDA granted a Priority Review for the sBLA and a Breakthrough Therapy Designation for the indication.  The application is the first to be submitted by Merck for the regulatory approval of Keytruda in a hematologic malignancy.
March 13,2017 Novartis Kisqali® (ribociclib, formerly LEE011) On Mar. 13, 2017, the FDA approved ribociclib, a a CDK4/6 inhibitor, as a first-line treatment for  postmenopausal women with HR+/HER2-advanced or metastatic breast cancer in combination with an aromatase inhibitor.  In the pivotal phase 3 MONALEESA-2 trial, treatment with Kisqali and the aromatase inhibitor letrozole reduced the risk of progression or death by 44% over letrozole alone. Pfizer’s rival breast cancer drug Ibrance (palbociclib) carries a similar (but broader) indication, and has a 45% market share in the first-line treatment of HR+/HER2- metastatic breast. Novartis plans to expand the breast cancer patient population for Kisqali and has two other registration studies ongoing - MONALEESA-3 and MONALEESA-7; preliminary efficacy data is expected as soon as late 2017.        
March 08,2017 Merck & Co. Keytruda® (pembrolizumab) An FDA decision on Merck’s supplemental Biologics License Application (sBLA) for Keytruda's expanded indication in previously treated patients with advanced microsatellite instability-high (MSI-H) cancer was due on March 8, 2017.  The company issued a statement after the market closed on that date saying that the marketing application remained under review and that it had submitted additional data and analyses related to the pending application to the FDA.  MSI-H is an established biomarker in certain types of cancer.        
February 28,2017 Lexicon Pharmaceuticals Xermelo™ (telotristat ethyl)
On Feb. 28, 2017 the FDA approved Xermelo (telotristat ethyl), a new, first-in-class oral therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.  Carcinoid syndrome is a rare and debilitating condition affecting people with metastatic neuroendocrine tumors (mNETs) for which SSA therapy is the current standard-of-care.  Xermelo, an orphan drug, will be available in specialty pharmacies by prescription as of March 6, 2017, and is expected to cost between $61K - $72K per patient per year.
February 24,2017 Celgene Corp. Revlimid® (lenalidomide) Celgene's key blood cancer drug, Revlimid, is currently under review for use as maintenance treatment in patients with newly diagnosed multiple myeloma (NDMM) after receiving an autologous stem-cell transplant (ASCT). A decision from the FDA is expected on Feb. 24.
February 23,2017 Clovis Oncology rucaparib

The company said on Aug. 23, 2016 that the FDA had accepted its NDA for the accelerated approval of rucaparib and granted priority review status to the application with a PDUFA date of Feb. 23, 2017. The proposed indication is for the treatment of patients with advanced mutant BRCA ovarian cancer who have had two or more prior therapies. Rucaparib was granted Breakthrough Therapy Designation for the indication in April 2015. A Premarket Approval (PMA) application has also been submitted to the FDA by Foundation Medicine for a companion diagnostic designed to identify tumor BRCA mutations, including germline and somatic BRCA mutations. Shares shot up in early September when Clovis announced it had been informed by the FDA that an Advisory Committee meeting to discuss the company's New Drug Application (NDA) for rucaparib would not take place.

January 11,2017 Tesaro Inc. Varubi® (rolapitant IV)

TESARO said on June 4, 2016 that the FDA had accepted for review its NDA for an intravenous (IV) formulation of rolapitant. Rolapitant IV is a potent and selective NK-1 receptor antagonist with an extended plasma half-life being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV). U.S. regulators have set a PDUFA target action date of Jan. 11, 2017.

2016

Date Company Product Event
December 31,2016 Soligenix Inc. SGX301 (Synthetic Hypericin)

Pivotal phase 3 results for SGX301 (Synthetic Hypericin) in CTCL are due 2H 2016; SGX301 has both Orphan Drug and Fast Track designations.

December 30,2016 Roche / Genentech Perjeta® (pertuzumab) & Herceptin® (trastuzumab)

Phase 3 results from the APHINITY trial of Perjeta and Herceptin combined with chemotherapy in the adjuvant breast cancer setting are expected at the end of 2016. If successful, the trial could signify a potential new standard of care (SoC) for breast cancer patients.

December 28,2016 Advanced Accelerator Applications Lutathera® (or lutetium Lu 177 dotatate)

The company said on June 27, 2016 that the FDA had accepted its NDA and granted Priority Review for Lutathera, a Lu-177-labeled somatostatin analogue peptide, being tested for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. The PDUFA target action date is Dec. 28, 2016. The NDA is partially based on results of the pivotal phase 3 NETTER-1 trial. The study demonstrated that treatment with Lutathera was associated with a statistically significant and clinically meaningful risk reduction of 79% in disease progression or death vs. treatment with a double dose of Octreotide LAR in patients with inoperable midgut NETs that had progressed under Octreotide LAR treatment and overexpressing somatostatin receptors.

December 26,2016 Amgen Xgeva® (denosumab)

Phase 3 data on the prevention of skeletal-related events (SREs) in patients with multiple myeloma is expected in H2 2016, according to the company's 2nd quarter earnings release (July 28, 2016).

December 25,2016 CytRx Corp. aldoxorubicin

A second analysis for CytRx's phase 3 trial of aldoxorubicin in second-line soft tissue sarcoma (STS) is due in the fourth quarter of 2016. The company currently anticipates reporting top-line results from a phase 2b second-line small cell lung cancer aldoxorubicin trial as well.

December 24,2016 Merck Keytruda® (pembrolizumab)

Merck said on Sept. 7, 2016 that the FDA had accepted for Priority Review its sBLA for Keytruda for the first-line treatment of patients with advanced NSCLC whose tumors express PD-L1. U.S. regulators assigned the application a PDUFA target action date of Dec. 24, 2016. The FDA also granted Breakthrough Therapy Designation for the indication. The sBLA was based on data from the KEYNOTE-024 study. In that pivotal phase 3 trial, Keytruda monotherapy demonstrated superior progression-free survival (PFS) as well as overall survival (OS) compared with standard chemotherapy in patients with advanced NSCLC whose tumors expressed high levels of PD-L1.

December 11,2016 Spectrum Pharmaceuticals Qapzola™ (apaziquone)

Spectrum issued a press release as soon as an FDA ODAC meeting ended on Sept. 14, 2016 saying that the panel had recommended against the approval of apaziquone. The advisory committee said that the investigational therapy had not shown substantial evidence of a treatment effect over placebo in patients with non-muscle invasive bladder cancer (NMIBC). Qapzola's proposed indication is for the immediate intravesical instillation post-transurethral resection of bladder tumors (post-TURBT) in patients with NMIBC. The company said the ODAC recommendation however was not binding on the FDA; U.S. regulators have set a PDUFA target action date of Dec. 11, 2016.

November 11,2016 Bristol-Myers Squibb Co. Opdivo® (nivolumab)

The company said on July 18, 2016 that both the FDA and the European Medicines Agency had accepted marketing applications for Opdivo as a possible treatment for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). U.S. regulators accepted BMS's supplemental Biologics License Application (sBLA) for Opdivo in SCCHN with a priority review, and assigned a projected FDA action date of Nov. 11, 2016. Opdivo is the first and only PD-1 inhibitor to show an overall survival benefit in a phase 3 trial (CheckMate -141) in this patient population. Nivo was previously granted a Breakthrough Therapy Designation for the indication.

October 22,2016 Medivation Inc. / Astellas Pharma Inc. Xtandi® (enzalutamide) capsules

Medivation announced on Feb. 22, 2016 that the sNDA for Xtandi in metastatic castration-resistant prostate cancer (CRPC) was accepted for review by the FDA. The sNDA includes findings from two head-to-head phase 2 studies of enzalutamide versus bicalutamide (TERRAIN and STRIVE) to update the relevant clinical sections within the current indication of metastatic castration-resistant prostate cancer. The PDUFA goal date for an FDA decision is October 22, 2016.

October 19,2016 Roche / Genentech Tecentriq® (atezolizumab)

The FDA approved Roche's new immunotherapy, Tecentriq (atezolizumab), on Oct. 18, 2016 for use in patients with advanced non-small cell lung cancer previously treated with chemotherapy, regardless of whether their tumors express the protein PD-L1. The approval was based on the results of the OAK and POPLAR trials; in those two phase 3 trials, when compared with the chemotherapy docetaxel, atezolizumab resulted in a 4.2 and a 2.9 month improvement in overall survival (OS), respectively.

October 10,2016 Exelixis, Inc. Cabometyx (cabozantinib)

New results from the phase 2 CABOSUN trial presented at ESMO demonstrated that cabozantinib significantly improved progression-free survival by 31% and substantially improved overall response rate when compared with Pfizer's Sutent (sunitinib) in previously untreated patients with metastatic renal cell carcinoma (RCC). While sunitinib is the standard of care and the most used agent in first-line metastatic RCC, the study’s lead investigator noted that cabozantinib had the potential to become a first-line treatment option for patients with RCC based on the CABOSUN data.

October 09,2016 Bristol-Myers Squibb Opdivo® (nivolumab)

In August 2016 BMS announced top-line results from CheckMate -026, a phase 3 study investigating the use of nivolumab as monotherapy, and said the study did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 at 5% or more. All eyes will be on ESMO as the company presents more complete data from that first-line study in Copenhagen. Results from CheckMate -026, a phase 3 study of Opdivo versus investigator’s choice of platinum-based doublet chemotherapy as a first-line therapy in a broad PDL-1 positive population with advanced non-small cell lung cancer (NSCLC) (LBA7_PR) will be presented during a Presidential Symposium on Sunday, October 9 at 5:35 – 5:50 p.m. CEST.

October 09,2016 Merck Keytruda® (pembrolizumab; pembro)

Two new studies of Keytruda in first-line treatment of advanced lung cancer have been selected for presentation at the Presidential Symposium on Sunday, Oct. 9, 4:25 – 6:20 pm CEST: KEYNOTE-024, which studied pembro as monotherapy compared to chemotherapy in patients with advanced NSCLC whose tumors express high levels of PD-L1 (tumor proportion score of 50% or more) (LBA8_PR), and KEYNOTE-021G, which studied pembro plus chemotherapy (carboplatin and pemetrexed) compared to chemotherapy alone in all patients with non-squamous non-small cell lung cancer (NSCLC) (LBA46_PR).

October 09,2016 Roche Tecentriq™ (atezolizumab)

At ESMO, positive results from the pivotal phase 3 lung cancer study ("OAK") will be presented at the Presidential Symposium 2 on Sunday, Oct. 9 (LBA44_PR). Roche recently announced that the study met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemotherapy.

October 08,2016 AstraZeneca Lynparza™ (olaparib)

A presentation of results from a negative, previously disclosed phase 3 study in gastric cancer of Lynparza, the only currently approved PARP inhibitor for ovarian cancer, will take place on Saturday, Oct. 8. While both Clovis Oncology and Tesaro will present highly anticipated data on their respective PARP inhibitors in ovarian cancer at ESMO, AstraZeneca is not expected to present any new Lynparza ovarian cancer data at the congress.

October 08,2016 Tesaro niraparib

The company announced in June that niraparib had successfully achieved the primary endpoint of a phase 3 study of second-line maintenance therapy in ovarian cancer patients. More data from the study will be presented at the meeting. Tesaro expects to file a new drug application before the end of 2016 based on data from the phase 3 study being presented at ESMO (ENGOT-OV16/NOVA trial) (LBA3_PR).

September 30,2016 Kite Pharma KTE-C19

Kite Pharma plans to announce interim results from the Zuma-1 study of KTE-C19, a CAR-T therapy to treat patients with advanced diffuse large B-cell lymphoma (DLBCL) before the end of September. If positive, the data will form the basis of an approval filing with the FDA by the end of 2016, meaning that Kite could be the first company to win approval of a CAR-T cancer therapy.

September 27,2016 Amgen Kyprolis® (carfilzomib)

The addition of Amgen's Kyprolis to chemotherapy in the phase 3 Clarion trial failed to show superiority over Takeda's Velcade (bortezomib) plus the same chemotherapy in patients with newly diagnosed multiple myeloma. Progression-free survival (PFS) for Kyprolis patients was 22.3 months compared to 22.1 months for patients in the Velcade arm. The failure of the trial was a setback for Amgen since the company hoped to boost sales for Kyprolis in the front-line setting while also justifying the high price tag of its Onyx purchase. An interim look at overall survival data, which is not yet mature, showed that Velcade patients were living longer than Kyprolis patients, Amgen said.

September 26,2016 Array BioPharma binimetinib (MEK162)

Array BioPharma said that top-line results from Part 1 of the pivotal phase 3 COLUMBUS trial, studying encorafenib in combination with the investigational MEK inhibitor binimetinib in patients with BRAF-mutant melanoma, demonstrated that the study met its primary endpoint, significantly improving progression free survival (PFS) compared with vemurafenib, a BRAF inhibitor, alone. The median PFS for patients treated with the encorafenib plus binimetinib combination was 14.9 mos. vs. 7.3 mos. for patients treated with vemurafenib. Binimentinib is currently under review by U.S. regulators as a treatment for patients with NRAS-mutant melanoma; the PDUFA target action date for that indication is June 30, 2017.

September 14,2016 Spectrum Pharmaceuticals Inc. Qapzola™ (apaziquone)

An FDA advisory panel concluded on Sept. 14, 2016 that the company's experimental bladder cancer treatment apaziquone wasn't effective in delaying the time to recurrence of the disease. The ODAC voted unanimously that Qapzola for immediate intravesical instillation post-transurethral resection of bladder tumors (post-TURBT) has not shown substantial evidence of a treatment effect over placebo in patients with non-muscle invasive bladder cancer (NMIBC). The company noted in their press release announcing the results that the panel’s recommendation is not binding on the FDA. Reporter Adam Feuerstein reported afterwards in a story in TheStreet that the FDA had advised Spectrum in Dec. 2012 not to file for approval of the drug since two clinical trials had already failed to benefit patients. The company did so anyway, the story reported, never advising investors about the FDA’s warning. In a May 2015 conference call with analysts/investors TheStreet’s story’s said, Spectrum's CEO misled investors when asked for an update on the drug and its interaction with the FDA. Two prior phase 3 studies of apaziquone in bladder cancer failed to meet their primary endpoints when topline results were reported. The PDUFA date for the Qapzola NDA is December 11, 2016.

September 01,2016 Amgen Inc. Blincyto® (blinatumomab) On Sept. 1, 2016 (its PDUFA target action date) the FDA approved Amgen's supplemental Biologics License Application (sBLA) for Blincyto to include new data supporting the treatment of pediatric patients with Philadelphia chromosome negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The indication was granted accelerated approval, and continued approval may be contingent upon verification of clinical benefit in subsequent trials. The approval is based on the Phase 1/2 '205, evaluating blinatumomab's efficacy and safety in pediatric patients with r/r B-cell precursor ALL.
August 31,2016 Genmab A/S / Novartis Arzerra® (ofatumumab)

After a Priority Review by the FDA and slightly ahead of its target action date of Sept. 10, 2016, Genmab's Arzerra was approved in combination with fludarabine and cyclophosphamide (FC) in relapsed chronic lymphocytic leukemia (CLL). The sBLA was based on results from the phase 3 COMPLEMENT 2 study, evaluating ofatumumab in combination with FC vs. FC alone in patients with relapsed CLL. The study met its primary endpoint of progression-free survival (PFS); patients receiving ofatumumab plus FC demonstrated a median PFS of 28.9 months, vs. 18.8 months for patients on FC alone. The approval, Arzerra's fourth, is the first globally for ofatumumab in combination with FC as a treatment for relapsed CLL.

August 16,2016 OncoGenex Pharmaceuticals Custirsen

The company announced results from the final analysis of AFFINITY, a phase 3 trial of custirsen in men with metastatic castrate-resistant prostate cancer (CRPC) whose disease has progressed after treatment with docetaxel. The trial did show a benefit in overall survival, the trial's primary endpoint, for patients treated with custirsen in combination with cabazitaxel/prednisone compared to cabazitaxel/prednisone alone. Final data are to presented as a late-breaking abstract at ESMO in October.

August 08,2016 Merck Keytruda® (pembrolizumab)

The FDA granted Keytruda an accelerated approval on Aug. 8, 2016 to treat patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. The approval is based on tumor response rate and durability of response. Data from the Phase Ib KEYNOTE-012 study demonstrated an objective response rate (ORR) of 16%, a complete response rate of 5%, with responses of six months or longer observed in 82% of patients responding to treatment. Continued approval depends upon verification and description of clinical benefit in the confirmatory trials. For HNSCC patients, Keytruda will be administered as a single agent at a 200 mg dose given intravenously every three weeks.

August 08,2016 Bristol-Myers Squibb Co. Opdivo® (nivolumab)

BMS announced on Aug. 5, 2016 that its blockbuster checkpoint inhibitor Opdivo failed to meet the main goal and delay disease progression or death compared with chemotherapy in a very important phase 3 trial (Checkmate 026) testing the PD-L1 inhibitor in newly diagnosed non-small cell lung cancer patients. The company's shares plunged 16% and the failure wiped $20 billion from the company's market value on the day of the announcement. By contrast, Merck’s immunotherapy, Keytruda, was found to prolong survival in a separate study of patients with newly diagnosed lung cancer, compared with chemotherapy. The difference in outcomes may have hinged on the patient populations of the two clinical trials: The Opdivo study included patients whose tumors had relatively low levels of PD-L1 protein, while the Merck trial only enrolled patients with relatively high levels of PD-L1, making it more likely that patients would benefit from the immunotherapy drug. Neither company has released the full results of the two studies yet.

July 18,2016 Roche / Genentech Gazyva® (obinutuzumab)

Roche said on July 18, 2016 that in the phase 3 GOYA study its new blood cancer drug Gazyva, combined with CHOP chemotherapy, did not significantly reduce the risk of disease or death for people with previously untreated diffuse large B-cell lymphoma (DLBCL) compared to the current older therapy Rituxan combined with CHOP. In two earlier studies, Gazyva had helped people with previously untreated follicular lymphoma or chronic lymphocytic leukemia live longer without their disease worsening versus Rituxan when each was combined with chemotherapy. It was a blow for Roche; the company is hoping that Gazyva will stave off competition from lower-priced biosimilars when Rituxan goes off patent in a few years if it can make the case for Gazyva’s benefit over generics in spite of its higher cost. Data from the study will be presented at an upcoming medical meeting, Roche said.

July 18,2016 AstraZeneca Plc Tagrisso™ (osimertinib, AZD9291)

AstraZeneca said on July 18, 2016 that its experimental lung cancer drug Tagrisso met the primary endpoint in the phase 3 AURA study. The oral tablet showed superior progression-free survival (PFS) compared to standard platinum-based chemotherapy in 419 patients with EGFR T790M mutation-positive, advanced non-small cell lung cancer (NSCLC) whose disease had progressed on or after treatment with a previous EGFR-TKI. Approved early, Tagrisso is the first medicine indicated for the treatment of adults with advanced EGFR T790M mutation-positive NSCLC. The company said a full evaluation of the data is ongoing, with results to be presented at a future medical meeting.

July 02,2016 XBiotech Inc. Xilonix™

The company plans to present positive preliminary findings on survival in advanced colorectal cancer from a pivotal phase 3 trial of its experimental lead therapy Xilonix, on July 2nd at the ESMO World Congress on Gastrointestinal Cancer in Barcelona. Xilonix was recently granted an accelerated review by the EMA. An approval decision could come as early as Q4 2016.

June 30,2016 CytRx Corp. aldoxorubicin

Shares of CytRx Corp. rose over 10% on Apr. 4, 2016 after the company announced that it had reached the target number of 191 events required to trigger the analysis of the primary endpoint of progression-free survival (PFS) in its pivotal, global phase 3 trial of aldoxorubicin in second-line soft tissue sarcoma. According to the lead investigator, the trial design is unique since it is the first trial in soft tissue sarcoma to compare a single agent to five of the most commonly used treatment options. Secondary endpoints in the trial include overall survival, response rates and safety. The company expects to announce top-line PFS data in June 2016.

June 30,2016 Galena Biopharma NeuVax™ (nelipepimut-S)

In the company's earnings release issued on Mar. 10, 2016, it said that an interim safety and futility analysis for the pivotal phase 3 PRESENT trial of NeuVax in recurrent breast cancer would be conducted by an Independent Data Monitoring Committee (IDMC) with results due at the end of the second quarter of 2016.

June 30,2016 Cyclical Pharmaceuticals sapacitibine

Phase 3 (SEAMLESS) top-line data in sapacitibine in acute myeloid leukemia (AML) is due at the end of the second quarter of 2016. The company said in mid-Dec. 2014 that an interim analysis suggests that the trial will fail.

June 30,2016 Tesaro Inc. Niraparib

Results from the phase 3 NOVA trial of niraparib in ovarian cancer are expected in Q2 2016. According to the company, the NOVA data will be the first from a randomized, prospective phase 3 trial of a PARP inhibitor.

June 28,2016 Clovis Oncology rociletinib

Clovis is seeking approval for its lead pipeline product, rociletinib, to treat patients with non-small cell lung cancer (NSCLC) with an EGFR gene mutation and who previously have been treated by another therapy that targets the gene. On Apr. 12, 2016, an FDA advisory committee recommended against accelerated approval of the oral therapy in a 12-1 vote and said that more clinical data from a phase 3 trial was needed. One of the panel's concerns was the risk of a fast and irregular heartbeat, a condition called QTc prolongation, for patients taking the drug and they recommended that the drug's labelling include a black box warning to advise about the heart risk. Since the additional clinical trial requested isn't expected to be completed until late 2018, Wall Street is skeptical about the drug's approval timeline.

June 17,2016 Merck Keytruda® (pembrolizumab)

Highly-anticipated results from the pivotal, phase 3 KEYNOTE-024 study demonstrated that Keytruda, when given as a first-line treatment to patients with advanced non-small cell lung cancer (NSCLC) whose tumors expressed high levels of PD-L1, was superior compared to chemotherapy for both the primary endpoint of progression-free survival (PFS) and the secondary endpoint of overall survival (OS). The trial compared treatment with a range of cytotoxic chemotherapy regimens to Keytruda monotherapy. An independent Data Monitoring Committee (IDMC) recommended that the trial be stopped based on the study's results, which will be presented at an upcoming medical meeting Merck said.

June 03,2016 Roche Molecular Systems cobas EGFR Mutation Test v2

On June 1, 2016 the FDA approved the first blood-based genetic test for the detection of epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer (NSCLC) patients. Roche's cobas EGFR Mutation Test v2 is a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib).

June 02,2016 Advanced Accelerator Application USA Netspot(TM) (Somakit-TATA) [kit for the Preparation of 68Ga-DOTATATE for Injection]

The FDA approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for use in positron emission tomography (PET) imaging, to aid in the detection of neuroendocrine tumors (NETs) in adult and pediatric patients. The company said that the kit has the potential to significantly improve the accuracy of NET diagnosis, in addition to reducing the radiation exposure for patients and drastically shortening the diagnostic procedure time versus SOC.

May 20,2016 Roche / Genentech Tecentriq™ (atezolizumab) injection

On May 18, 2016 the FDA granted an accelerated approval to Genentech's Tecentriq for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The FDA approval was particularly notable for several reasons: Tecentriq is the first immunotherapy ever approved for this type of cancer, and there have been no significant new medicines for bladder cancer in years.

May 18,2016 Bristol-Myers Squibb Co. Opdivo® (nivolumab)

The FDA granted accelerated approval on May 17, 2016 to Bristol-Myers's Opdivo for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin (Adcetris). The approval is the first for a PD-1 inhibitor in a hematological malignancy. The accelerated approval is based on overall response rate (ORR) and on data from the phase 2 CheckMate -205 and the phase 1 CheckMate -039 trials. Based on an analysis of that data, Opdivo delivered an ORR of 65%. Among responders, the duration of response was maintained for a median of 8.7 months. The application was approved well before the PDUFA goal date of Sept. 1, 2016.

May 18,2016 AstraZeneca PLC Lynparza® (olaparib)

On May 18, 2016 the company announced top-line results from the phase 3 GOLD trial and said that its ovarian cancer drug Lynparza failed to meet its primary goal of improving overall survival (OS) in patients with advanced gastric cancer in either the overall population or patients whose tumour tested negative for Ataxia-Telangectasia Mutated (ATM) protein. There was a difference between patients who took olaparib combined with chemotherapy (paclitaxel) and those who took paclitaxel alone, but it wasn’t statistically significant, the drugmaker said. AZ noted that it still had high hopes for Lynparza in other cancers as GOLD's regimen was unusual from other phase 3's testing olaparib in the low dose given and its combination with a standard chemotherapy. Results of the trial are to be submitted for presentation at an upcoming medical meeting.

May 18,2016 Novartis LEE011 (ribociclib)

An Independent Data Monitoring Committee recommended stopping the MONALEESA-2 trial of ribociclib early when an interim analysis showed that the pivotal phase 3 study significantly extended progression free survival (PFS) in women with HR+/HER2-advanced breast cancer. Novartis said that LEE011 (ribociclib), a CDK4/6 inhibitor, combined with letrozole, showed clinically meaningful improvement in PFS in postmenopausal women who had received no prior therapy for advanced breast cancer, compared to letrozole alone. The company said the study's full results would be presented at an upcoming medical meeting, and that it planned to initiate regulatory discussions worldwide.

May 17,2016 Eisai Inc. Lenvima® (lenvatinib)

The FDA on May 13, 2016 approved Eisai's Lenvima in combination with Novartis’ Afinitor (everolimus) for patients with advanced renal cell carcinoma (RCC) whose disease has progressed despite prior anti-angiogenic therapy. The approval marks "the first and only FDA-approved regimen successfully combining tyrosine kinase and mTOR inhibition treatments," according to the lead investigator of the trial on which the approval is based. Data from the phase 2 trial (Study 205) demonstrated that the combination of Lenvima (lenvatinib)/everolimus resulted in a median PFS almost 3x that of everolimus alone (median PFS 14.6 months versus 5.5 months, respectively). Lenvima was initially approved in Feb. 2015 for advanced radioactive iodine-refractory differentiated thyroid cancer. The FDA decision came just a few days ahead of the PDUFA action date of May 16, 2016.

May 11,2016 NewLink Genetics Corp. algenpantucel-L

Shares of NewLink plunged 37% in extended trading on May 9, 2016 after the company said that its experimental immunotherapy for resected pancreatic cancer failed to improve overall survival, the study’s primary endpoint, in a phase 3 trial. Patients treated with algenpantucel-L lived for a median of 27.3 months in the IMPRESS trial compared to median survival of 30.4 months for patients treated with standard therapy. There was no statistically significant difference reported for either overall survival or long-term survival between the study and control groups. In May 2015 NewLink said it would let the trial continue after announcing that it planned to file for approval if interim data showed an improvement in overall survival rates. When the trial wasn’t stopped at the interim stage, analysts surmised that the trial would probably fail.

April 25,2016 Exelixis, Inc. Cabometyx® (cabozantinib)

On April 25, 2016, the FDA approved Exelixis' Cabometyx (cabozantinib) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. The approval came several months ahead of the FDA action date of June 22, 2016.

April 19,2016 Heron Therapeutics SUSTOL® (granisetron) Injection, extended release

After the PDUFA date was pushed back twice earlier in the year, the company issued a release on Mar. 3 saying that the FDA anticipated concluding its review of the NDA for Sustol "by early April 2016.” On Apr. 18, Heron issued another release to provide an update on the progress of the FDA's review — it said the agency had indicated there "were no substantive deficiencies in the NDA” and that it had begun labeling discussions with the FDA. Sustol's proposed indication is for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC).

April 15,2016 Boehringer Ingelheim Gilotrif® (afatinib) tablets

On Apr. 15, 2016 the FDA approved a supplemental New Drug Application (sNDA) for Gilotrif as a new oral treatment option for patients with advanced squamous cell carcinoma (SqCC) of the lung whose disease has progressed after treatment with platinum-based chemotherapy. The approval is based on data from the phase 3 head-to-head LUX-Lung 8 study, in which patients with SqCC of the lung on afatinib showed significantly improved overall survival and progression-free survival vs those on Tarceva® (erlotinib). Gilotrif, an oral, once-daily EGFR-directed therapy, is currently approved in the U.S. for the first-line treatment of specific types of EGFR mutation-positive NSCLC as detected by an FDA-approved test.

April 12,2016 Clovis Oncology rociletinib (Xegafi)

On Apr. 12, 2016, in a negative 12-1 vote, an ODAC gave a thumbs down to the accelerated approval of Clovis' experimental oral lung cancer agent rociletinib and recommended that the FDA wait for results from an ongoing phase 3 study (TIGER-3) before deciding whether or not to approve the therapy. The company's stock hit a 52-week low earlier in the week after the release of unfavorable FDA briefing documents. Analysts say it doesn't look likely that the Agency will grant approval of rociletinib by the PDUFA date of June 28, 2016. Patient enrollment in the TIGER-3 study isn't expected to complete until late 2018.

April 11,2016 AbbVie & Roche / Genentech Venclexta tablets (venetoclax)

On Apr. 11, 2016, the FDA approved venetoclax (Venclexta tablets) for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. Up to 50% of people whose CLL has progressed have 17p deletion, a genetic marker that makes the disease difficult-to-treat, according to Genentech. In a pivotal single-group phase 2 trial of 107 CLL patients with the 17p deletion, data on which the FDA approval was based, venetoclax demonstrated an overall response rate of 79.4%, and response was maintained in roughly 85% of most patients after a year.

March 31,2016 Jazz Pharmaceuticals Defitelio (defibrotide sodium)

A day ahead of the PDUFA date, U.S. regulators approved Jazz Pharma's Defitelio for the treatment of adults and children who develop hepatic veno-occlusive disease (VOD) with evidence of multi-organ dysfunction (MOD) following hematopoietic stem-cell transplantation (HSCT). It is the first FDA-approved therapy for hepatic VOD, a rare and life-threatening liver condition.

March 16,2016 Celator Pharmaceuticals Vyxeos™ (cytarabine: daunorubicin) Liposome for Injection (also known as CPX-351)

Celator's stock quintupled after the company announced that a pivotal phase 3 trial of Vyxeos Liposome for Injection, or CPX-351, met its primary endpoint, demonstrating a statistically significant improvement in overall survival. The study compared CPX-351 to the standard of care regimen (cytarabine and daunorubicin or 7+3) in patients with untreated high-risk (secondary) acute myeloid leukemia (AML). The median overall survival for patients treated with Vyxeos was 9.56 months compared to 5.95 months for patients receiving 7+3, or a 3.61 month improvement in favor of Vyxeos. The company plans to submit the data for presentation at ASCO 2016 and said it will also file marketing applications for the therapy with both U.S. and European regulators. The study's lead investigator said that the trial's results, including the overall survival advantage and superior response rate, heralded a possible new standard of care for treating older patients with secondary AML.

March 16,2016 Spectrum Pharmaceuticals Evomela™ (melphalan) for Injection

Evomela received FDA approval on Mar. 15, 2016 for use in two indications: 1) as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in patients with multiple myeloma (MM), and 2) for the palliative treatment of patients with MM for whom oral therapy is not appropriate. Evomela is the first product to be FDA-approved for the high-dose conditioning indication in MM and was earlier granted an Orphan Drug Designation for that indication.

March 12,2016 Pfizer Xalkori® (crizotinib)

After a priority review, the FDA expanded the use of Pfizer’s oral drug Xalkori to treat a small subset of lung cancer patients with a rare ROS-1 gene mutation. The FDA approved the new indication based on a 50-patient study in which 66 percent of patients saw their tumor shrink partially or completely. The benefit lasted about 18 months for the typical patient. The FDA nod makes Xalkori the first FDA-approved biomarker-driven therapy for the treatment of ROS1-positive metastatic non small cell lung cancer (NSCLC).

March 08,2016 Celldex Therapeutics, Inc. Rintega® (rindopepimut)

Celldex said it was discontinuing its clinical development of Rintega, after an interim analysis of a pivotal phase 3 study (ACT IV) conducted by independent data monitors, showed that the primary endpoint of the study, overall survival, was not met. Rintega reduced the risk of death by just 1% compared to the control arm. At the median, Rintega-treated patients survived 20.4 months compared to 21.1 months for the control arm, the company said. Rintega was being tested in 745 patients with newly diagnosed and EGFRvIII-positive glioblastoma multiform (GBM) who underwent surgery to remove their tumors, followed by standard radiation and chemotherapy. After that baseline treatment, patients were randomized into two arms with half receiving treatment with Rintega plus standard chemotherapy; and the other half receiving a control injection plus standard chemotherapy.

March 05,2016 AbbVie / Janssen Biotech Imbruvica® (ibrutinib)

Imbruvica was approved on Mar. 4, 2016 by the FDA as a first-line treatment for patients with chronic lymphocytic leukemia (CLL). The newly-approved indication makes it the first FDA-approved chemotherapy-free treatment option for first-line CLL patients. The approval is based on data from the phase 3 RESONATE™-2 trial which showed an 84% reduction in the risk of progression or death with Imbruvica versus chlorambucil.

March 02,2016 AstraZeneca Faslodex® (fulvestrant)

The FDA approved on Mar. 2, 2016 an expanded use for Faslodex in combination with palbociclib, AstraZeneca said. The combination use is for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy. The approval for the new indication is based on data from the phase 3 PALOMA-3 trial. In that trial, the combination of fulvestrant 500 mg and palbociclib 125 mg resulted in a 4.9 month progression-free survival (PFS) improvement over fulvestrant and placebo, in women with HR+ HER2- advanced or MBC whose disease had progressed after endocrine therapy. Faslodex has been approved since 2002 as a monotherapy for postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy.

February 27,2016 Genentech / Roche Gazyva® (obinutuzumab)

The FDA approved Gazyva for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.

February 27,2016 Novartis Afinitor® (everolimus)

The FDA approved Afinitor for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease.

February 19,2016 Pfizer Ibrance® (palbociclib)

Two months ahead of the April PDUFA date, the FDA approved Pfizer's supplemental New Drug Application (sNDA), expanding Ibrance's use for women with HR+, HER2- advanced or metastatic breast cancer in combination with fulvestrant, in women with disease progression after endocrine therapy.

February 11,2016 Incyte Corp. Jakafi® (ruxolitinib)

The company said it would stop testing Jakafi in solid tumor cancers, including colorectal, breast and lung cancers, after the blood cancer treatment failed to show a survival benefit in a phase 3 trial (JANUS 1) when combined with chemotherapy in second-line pancreatic cancer. An analysis of the data, Incyte said, did not show a "sufficient level of efficacy to warrant continuation." The first-in-class JAK1/JAK2 inhibitor is the first and only drug approved in the U.S. to treat two rare blood cancers, polycythemia vera (PV) and myelofibrosis (MF), and is Incyte's only marketed product.

February 04,2016 Merck Emend® (fosaprepitant dimeglumine) for Injection

The FDA approved an expanded indication for Emend in combination with other antiemetic agents, for the prevention of delayed nausea and vomiting in adults receiving moderately emetogenic chemotherapy (MEC). The additional approval makes Emend the first intravenous single-dose NK1 receptor antagonist approved in the U.S. for both highly emetogenic chemotherapy (HEC) as well as MEC.

February 02,2016 Telesta Therapeutics MCNA

Telesta said on Feb. 2, 2016 that it had received a Complete Response Letter from the FDA regarding its BLA for its investigational bladder cancer therapy, MCNA. The Agency said an additional phase 3 trial would be necessary in order to establish the therapy's efficacy and safety. U.S. regulators had earlier given the company's marketing application a Priority Review and assigned Feb. 27, 2016 as the review goal data. MCNA is a biologic therapy developed to provide high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy with an alternative to surgery.

January 30,2016 Bristol-Myers Squibb Co. Opdivo® (nivolumab)

The company said on Jan. 28, 2016 that the pivotal phase 3 CheckMate -141 trial of nivolumab versus investigator’s choice in patients with head and neck cancer was stopped early. An independent Data Monitoring Committee (DMC) determined that the study had met its primary endpoint, showing superior overall survival (OS) in patients receiving Opdivo compared to the control arm. BMS said that it would evaluate the final study data, and would work with investigators to present and publish the trial's results in the future.

January 29,2016 Eisai Inc. Halaven® (eribulin mesylate)

The FDA approved Eisai's Halaven, a type of chemotherapy, as a treatment for liposarcoma that either cannot be removed by surgery or is advanced. Liposarcoma is a specific type of soft tissue sarcoma (STS) that occurs in fat cells. Halaven is the first drug approved to show survival benefit in the disease. Halaven is approved for patients who received prior chemotherapy that contained an anthracycline drug. In a trial of 143 patients, the median overall survival for patients with liposarcoma receiving Halaven was 15.6 months compared to 8.4 months for those who received another type of chemotherapy, dacarbazine. The FDA had previously granted Halaven both priority review status and orphan drug designation.

January 24,2016 Bristol-Myers Squibb Co. Opvido® (nivolumab)

On Jan. 23, 2016 U.S. regulators approved Opdivo in combination with ipilimumab (Yervoy) for the treatment of unresectable or metastatic melanoma including both BRAF-wild type and BRAF-mutant melanoma. The FDA also expanded the indication for single-agent nivolumb to include patients with previously untreated BRAF-wild type melanoma. Granted by the FDA's accelerated approval process, the indication is the seventh for nivolumab. The FDA based the approval on results from the phase 3 CheckMate-067 trial, which compared nivolumab plus ipilimumab or nivolumab alone versus ipilimumab monotherapy. The results showed a median PFS of 11.5 months with the combination, 6.9 months with nivolumab alone, and 2.9 month with ipilimumab alone.

January 21,2016 Amgen Kyprolis® (carfilzomib) for Injection

The FDA approved Amgen's sNDA for Kyprolis in combination with dexamethasone or with lenalidomide (Revlimid) plus dexamethasone for patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The Agency also approved Kyprolis as a single agent for patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. The FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent. The application is based on data from the phase 3 head-to-head ENDEAVOR trial. Patients with relapsed multiple myeloma in the study treated with Kyprolis and low-dose dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over bortezomib (Velcade) and low-dose dexamethasone, the current standard of care in relapsed multiple myeloma (median progression-free survival [PFS] 18.7 months vs. 9.4 months).

January 19,2016 Genmab A/S / Novartis Arzerra® (ofatumumab)

The FDA on Jan. 19, 2016 approved the sBLA for Arzerra for the extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). The approval is based on data from the phase 3 PROLONG study, which demonstrated that patients receiving Arzerra maintenance treatment lived 13.4 months longer without their disease worsening than those receiving no further treatment (median progression free survival (PFS) of 28.6 months vs. 15.2 months, respectively). Arzerra is already approved in the US in combination with chlorambucil for previously untreated patients with CLL who can’t take fludarabine-based therapy.

2015

Date Company Product Event
December 18,2015 Merck Keytruda® (pembrolizumab)

The FDA on Dec. 18, 2015 approved an expanded indication for Merck's anti-PD-1 therapy pembrolizumab as a first-line treatment for patients with advanced melanoma. The approval was based on data from the phase 3 KEYNOTE-006 study in which patients with unresectable or metastatic melanoma who were treated with Keytruda showed superior overall survival (OS) compared to those treated with ipilimumab. U.S. regulators also approved updated product labeling for Keytruda's indication for ipilimumab-refractory advanced melanoma, based on results from the phase 2 KEYNOTE-002 trial demonstrating pembro's superiority to chemotherapy. The clinical benefit demonstrated in the trial conferred a full approval on the ipilimumab-refractory indication.

December 12,2015 Roche / Genentech Alecensa® (alectinib)

Genentech announced on Dec. 11, 2015 the FDA's accelerated approval of alectinib, which will be marketed as Alecensa, for people with ALK-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. The indication was given an accelerated approval based on tumor response rate and duration of response (DOR) in pivotal studies.

December 11,2015 Wellstat Therapeutics Corp. Vistogard® (uridine triacetate)

On Dec. 11, 2015 the FDA approved Vistogard for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.

December 08,2015 Threshold Pharmaceuticals / Merck KGaA evofosfamide (previously known as TH-302)

In a major setback for both companies, Threshold and partner Merck KGaA announced on Dec. 7, 2015 that two pivotal phase 3 trials of evofosfamide combined with chemotherapy in advanced pancreatic cancer (MAESTRO) and advanced soft tissue sarcoma (TH-CR-406/SARC021) failed to meet their primary endpoints of improving overall survival (OS) with statistical significance. Evofosfamide, an investigational hypoxia-activated prodrug, was being evaluated as a first-line treatment for both types of cancer. Both companies said they would not pursue any further development of evofosfamide in those two indications, and that detailed results from both studies would be submitted for presentation at an upcoming scientific meeting. Merck said it planned to make a "quick decision on the future of the ongoing evofosfamide clinical program” and would instead focus on its main pipeline asset, avelumab. The anti-PD-L1 antibody received breakthrough therapy designation from the FDA recently as a treatment for metastatic Merkel cell carcinoma.

December 01,2015 Bristol-Myers Squibb Co. / AbbVie Empliciti (elotuzumab)

The FDA approved on Nov. 30, 2015 Bristol-Myers Squibb's Empliciti in combination with dexamethasone and Celgene's Revlimid to treat multiple myeloma. In November, U.S. regulators also approved two other drugs for multiple myeloma, Janssen Biotech’s Darzalex and Takeda's Ninlaro. The agency granted Empliciti breakthrough therapy designation, priority review and orphan-drug designation.

November 24,2015 Bristol-Myers Squibb Co. Opdivo® (nivolumab)

A few days ahead of its FDA action date of Nov. 27, 2015, the agency greenlighted a new indication for Opdivo, making it the first and only PD-1 immune checkpoint inhibitor approved as a single agent for first-line use in advanced BRAF wild-type melanoma. The approval is based on the phase 3 CheckMate -066 trial, in which Opdivo demonstrated superior overall survival vs. dacarbazine in first-line treatment of patients with BRAF wild-type advanced melanoma.

November 24,2015 Eli Lilly & Co. Portrazza™ (necitumumab)

On Nov. 24, 2015, the FDA approved Lilly's Portrazza, in combination with gemcitabine and cisplatin, as the first biologic for the first-line treatment of people with metastatic squamous non-small cell lung cancer. The approval is based on the results of the phase 3 SQUIRE trial, comparing first-line treatment with Portrazza plus gemcitabine and cisplatin to gemcitabine and cisplatin alone in patients with metastatic squamous NSCLC, with overall survival as the primary endpoint. According to Lilly, SQUIRE was the first and only randomized phase 3 study conducted specifically in patients with metastatic squamous NSCLC to demonstrate a statistically significant improvement in overall survival over gemcitabine and cisplatin alone, specifically in the first-line setting. In the trial, median overall survival was 11.5 months for patients on Portrazza combination therapy compared to 9.9 months for patients treated with gemcitabine and cisplatin alone translating to a 16% reduction in risk of death. Portrazza has been granted Orphan Drug Designation by the FDA.

November 24,2015 Bristol-Myers Squibb Co. Opdivo® (nivolumab)

Just a week after BMS announced that the sBLA had been accepted for a priority review by the FDA on Nov. 16, the agency approved an additional indication for Opdivo as a treatment for patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. In announcing the approval, the FDA said that Opdivo was one of few therapies that had demonstrated the ability to extend patients’ survival in kidney disease. The quick approval was based on data from CheckMate -025 in which patients treated with Opdivo had a median overall survival benefit of 25 months, compared with 19.6 months in the group that received Novartis' Afinitor. BMS stopped the clinical trial early in July when the data monitoring committee found that the study had already met its primary endpoint of overall survival. The agency previously granted Opdivo Breakthrough Therapy Designation for the RCC indication. The expanded use for BMS' PD-1 inhibitor was greenlighted by US regulators well ahead of the projected FDA action date of Mar. 16, 2016.

November 20,2015 Takeda Pharmaceuticals Ninlaro (ixazomib)

The FDA approved Takeda's Ninlaro for multiple myeloma patients who have received one or more prior therapies. Ninlaro is the first oral proteasome inhibitor approved for MM and is approved in combination with lenalidomide (Revlimid, Celgene) and the corticosteroid dexamethasone. The three-agent combination is the first all-oral regimen for MM.

November 16,2015 Janssen Pharmaceuticals (Johnson & Johnson) / Genmab A/S Darzalex (daratumumab)

The FDA approved Janssen's Darzalex, a novel option for patients with multiple myeloma who have tried at least three other drug therapies, and the first monoclonal antibody for use in the disease. Daratumumab had been designated as a Breakthrough Therapy for this patient population. The approval came earlier than the drug's PDUFA date of Mar. 9, 2016 after a Priority Review by U.S. regulators. Daratumumab's safety and efficacy has been shown in two open-label studies: In one study of 106 patients on daratumumab, 29% had a complete or partial reduction in their tumor burden lasting for an average of 7.4 months; in the second study of 42 patients on the drug, 36% had a complete or partial reduction in their tumor burden.

November 13,2015 AstraZeneca Tagrisso™ (osimertinib, AZD9291)

On Nov. 13, 2015 the FDA approved Tagrisso 80mg once-daily tablets for patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. The new therapy is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer.

November 11,2015 Roche / Genentech & Exelixis Cotellic™ (cobimetinib) / Zelboraf® (vemurafenib)

On Nov. 10, 2015 the FDA approved Cotellic in combination with Zelboraf to treat some patients with BRAF V600 mutation-positive advanced melanoma. The approval was based on results from the pivotal phase 3 coBRIM study in which the combination of the two drugs improved progression-free and overall survival compared to Zelboraf alone. The data in the trial demonstrated a median PFS of 12.3 months for Cotellic plus Zelboraf versus 7.2 months for Zelboraf alone, while an interim analysis has also shown that the combination helped patients live significantly longer, Roche said.

October 28,2015 Bristol-Myers Squibb Co. Yervoy® (ipilimumab)

The FDA approved, on October 28, 2015, an additional indication for ipilimumab as an adjuvant treatment for patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection.

October 27,2015 Amgen Imlygic™ (talimogene laherparepvec) (also called T-Vec)

On October 27, 2015 the FDA approved Imlygic, a first-in-class oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes.

October 24,2015 Spectrum Pharmaceuticals Evomela™ (melphalan hydrochloride) for injection

Spectrum said on Oct. 23, 2015 that the FDA had declined to approve Evomela injection as a treatment for patients with multiple myeloma (MM). The company received a Complete Response Letter (CRL) from the FDA, although the agency did not identify any clinical deficiency in its application, Spectrum said. The company said it would continue to work with the FDA to bring the therapy to market. Evomela has been granted Orphan Drug Designation for its use as a high-dose conditioning regimen for patients with MM undergoing ASCT.

October 24,2015 Johnson & Johnson (Janssen Pharmaceuticals) Yondelis® (trabectedin)

About a month ahead of schedule on October 23, 2015, the FDA approved Janssen's chemotherapy trabectedin for the treatment of patients with unresectable or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS) who have received a prior anthracycline-containing regimen. Yondelis is the first treatment to be specifically approved for LPS in the U.S.

October 22,2015 Merrimack Pharmaceuticals Onivyde™ (irinotecan liposome injection) (formerly known as MM-398)

A few days ahead of the PDUFA action date, the FDA approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The drug was approved for marketing with labelling indicating the risks of severe neutropenia and diarrhea as side effects. The NDA was based on results of the phase 3 NAPOLI-1 study in which Onivyde combined with fluorouracil (5-FU) and leucovorin demonstrated a statistically significant improvement in overall survival, progression free survival and overall response rate compared to a control group who received 5-FU and leucovorin only. This was the first global late-stage study in a post-gemcitabine setting to show a survival benefit in pancreatic cancer.

October 09,2015 Bristol-Myers Squibb Co. Opdivo® (nivolumab)

On October 9, 2015 the FDA expanded the approved use of nivolumab to include the treatment of patients with metastatic nonsquamous, non-small-cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy. Earlier in 2015, Opdivo was approved for patients with previously treated squamous NSCLC. U.S. regulators also approved the PD-L1 IHC 28-8 pharmDx test to detect PD-L1 protein expression levels and help physicians determine which patients would benefit most from the drug. The new approval is based on the CheckMate 057 study results showing that median overall survival was about 3 months longer with nivolumab than with docetaxel in patients with advanced nonsquamous NSCLC who had progressed on platinum-doublet chemotherapy (a subset of patients with high levels of PD-L1 expression derived even greater benefit from nivo). The new approval occurred 3 months ahead of the FDA action date of January 2, 2016. Opdivo has been designated a Breakthrough Therapy for the indication.

October 08,2015 Roche / Genentech & Exelixis Cotellic (cobimetinib)

The companies said on Oct. 6, 2015 that final survival data from the phase 3 coBRIM trial showed that Cotellic used in combination with Zelboraf® (vemurafenib) helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer versus Zelboraf alone. The specific data will be presented at an upcoming medical conference. Long-term safety data is expected later this year. The FDA is slated to make an approval decision on Roche's new drug application by Nov. 11, 2015.

October 03,2015 Merck Keytruda® (pembrolizumab)

On Oct. 2, 2015, the FDA cleared Merck's Keytruda to treat certain patients with advanced cases of the most common form of lung cancer. U.S. regulators granted accelerated approval to Keytruda for patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and whose tumors express the PD-L1 protein. Keytruda is approved for use with a companion diagnostic from Dako, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1.

October 01,2015 Bristol-Myers Squibb Co. Opdivo (nivolumab) + Yervoy (ipilimumab)

Marking the FDA's first and only approval for a combination of two immuno-oncology drugs, Bristol-Myers said on Oct. 1, 2015 that U.S. regulators had approved an Opdivo + Yervoy regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. The approval is based on data from the pivotal CheckMate -069 study in which the combination of the two drugs delayed the spread of cancer by 8.9 months compared with 4.7 months for Yervoy alone.

September 24,2015 Taiho Oncology Lonsurf® (trifluridine and tipiracil), formerly TAS-102

The FDA approved Lonsurf, from Taiho Oncology, on Sept. 22, 2015 to treat refractory metastatic colorectal cancer in patients previously treated with chemotherapy, an anti-VEGF biological therapy, and if Ras wild-type, an anti-EGFR therapy. The approval is based on results from the pivotal phase 3 RECOURSE trial which demonstrated a significant survival benefit for patients with refractory mCRC whose disease had progressed after standard therapies, reducing the risk of death in these patients by 32% compared to placebo. Lonsurf, which has Fast Track designation, was approved ahead of its Dec. 19, 2015 PDUFA date. It's the first FDA-approved product for Taiho Oncology, and is already approved in Japan. The company plans to make the drug available in the U.S. this month, at which time it will announce the price.

September 03,2015 Tesaro Varubi™ (rolapitant)

A few days ahead of its action date of Sept. 5, 2015, Tesaro received FDA approval for oral rolapitant, which will be marketed as Varubi, a drug for the prevention of chemotherapy induced nausea and vomiting (CINV) in adults. Varubi is the company's first approved product. The approval comes at a time when similar supportive care therapies, such as Merck & Co's oral drug Emend, are losing patent protection. Tesoro is also testing an intravenous (IV) formulation of rolapitant.

August 18,2015 Seattle Genetics, Inc. Adcetris® (brentuximab vedotin)

Seattle Genetics announced on Apr. 20th, 2015 that the FDA had accepted its supplemental BLA for the post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression. The FDA granted Priority Review for the application and the PDUFA target action date is August 18, 2015. The submission is based on positive results from the phase 3 AETHERA trial. Adcetris is approved in relapsed HL and sALCL but is currently not approved for consolidation therapy in HL patients immediately after ASCT.

July 26,2015 Amgen Kyprolis® (carfilzomib)

On July 24, 2015 the FDA approved Amgen's supplemental New Drug Application (sNDA) for Kyprolis in combination with Revlimid® (lenalidomide) and dexamethasone (KRd) for patients with multiple myeloma who have received one to three prior lines of therapy.

July 26,2015 Novartis Odomzo® (sonidegib, formerly LDE225)

On July 24, 2015 the FDA approved Novartis' Odomzo® (sonidegib) capsules for adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.

July 23,2015 AstraZeneca PLC selumetinib

AstraZeneca announced that the phase 3 SUMIT study, testing the MEK inhibitor selumetinib in combination with dacarbazine in patients with metastatic uveal melanoma, failed to meet its primary endpoint of progression free survival. Selumetinib is being investigated primarily as a treatment for advanced non-small cell lung cancer (NSCLC).

July 21,2015 Exelixis Cometriq® (cabozantinib, formerly XL184)

Exelixis announced positive top-line results from the phase 3 pivotal METEOR study testing Cometriq (cabozantinib) in advanced kidney cancer vs Novartis' Afinitor (everolimus). Cabozantinib reduced the risk of disease progression or death by 42% compared to everolimus in the trial, thus meeting the primary endpoint of significantly improving progression-free survival (PFS). METEOR tested the drug in patients who no longer responded to at least one VEGF-targeted drug such as Pfizer's Sutent (sunitinib).

July 21,2015 Bristol-Myers Squibb Co. Opdivo® (nivolumab)

An independent data monitoring committee stopped a phase 3 trial of Bristol-Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) early after an interim analysis showed a survival benefit in advanced kidney cancer patients. The PD-1 inhibitor beat Afinitor (everolimus) in improving overall survival. The company said it was the first time an immuno-oncology agent had shown a survival advantage in advanced renal cell carcinoma (RCC).

July 14,2015 AstraZeneca PLC Iressa® (gefitinib)

The FDA, on July 13, 2015, approved AstraZeneca's Iressa for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a specific genetic mutation (epidermal growth factor receptor [EGFR]), as identified by a newly approved companion diagnostic test made by QIAGEN.

July 09,2015 Eli Lilly & Co. necitumumab In spite of a risk of sometimes fatal blood clots, an FDA panel gave a nod on June 9, 2015 to Lilly's experimental lung cancer drug necitumumab as a potential first-line treatment, in combination with chemotherapy agents gemcitabine and cisplatin, for patients with squamous non-small cell lung cancer (NSCLC). Lilly issued a statement saying that necitumumab, in combination with chemotherapy, was the first regimen to show a significant improvement in overall survival over chemo alone, specifically in the first-line setting. The FDA is expected to make a decision on Lilly's biologics license application for necitumumab later this year.
March 30,2015 Wellstat Therapeutics Uridine Triacetate

The FDA is reviewing the NDA for the company’s investigational drug uridine triacetate as an antidote for patients at risk of serious toxicity following an overdose of chemotherapy agent 5-fluorouracil (5-FU), and patients who exhibit serious toxicity within 96 hours of being treated with 5-FU. U.S. regulators are expected to make an approval decision in March 2016.

March 08,2015 Novartis / Sandoz Zarxio™ (filgrastim-sndz)

The FDA gave the greenlight to Novartis/Sandoz's biosimilar Zarxio on Mar. 6, 2015, making it the first copycat version of a biologic drug to be approved for the U.S. market. The Novartis biosimilar is a knockoff of Amgen's blockbuster drug Neupogen, which boosts the blood cells of cancer patients. U.S. regulators approved Zarxio for use in several types of patients, including those undergoing bone marrow transplants or receiving certain forms of chemotherapy.

February 24,2015 Novartis AG Farydak® (panobinostat, formerly LBH589)

The FDA approved Novartis' drug panobinostat (brand name: Farydak) in combination with Takeda's Velcade (bortezomib) and dexamethasone for patients whose multiple myeloma has relapsed after treatment with at least two prior therapies. A November FDA advisory panel voted 5 to 2 against recommending that the drug be approved due to serious side effects including severe diarrhea and heart problems. In the phase 3 PANORAMA-1 trial, panobinostat prolonged median PFS in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone (from 6 to 11 months). The FDA granted the drug conditional approval, which means that the company will have to demonstrate the drug's further benefit in confirmatory trials to gain full approval. Farydak is the first histone deacetylase (HDAC) inhibitor available to treat patients with multiple myeloma.

February 20,2015 Celgene Corp. Revlimid® (lenalidomide)

On Feb. 18, 2015 the FDA expanded approval of Revlimid, in combination with dexamethasone, to include newly diagnosed multiple myeloma patients. The expanded approval was supported by phase 3 studies, including the FIRST trial comparing Revlimid plus dexamethasone to melphalan, prednisone and thalidomide in over 1500 patients newly diagnosed with multiple myeloma who were not candidates for stem cell transplantation. Treatment with Revlimid plus dexamethasone was associated with a median progression-free survival of 25.5 months, versus 21.1 months for the triple regimen; median overall survival was 58.9 months in the Revlimid/dexamethasone arm compared to 48.5 months for patients who received the triple regimen. The drugmaker is also seeking approval for Revlimid as a first-line treatment in Europe.

February 13,2015 Eisai Inc. Lenvima™ (lenvatinib)

On Feb. 13, 2015, the FDA granted approval to Eisai's Lenvima (lenvatinib) as a treatment for locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. The drug won approval 2 months before its PDUFA date of Apr. 14, 2015. Lenvima's approval was based on results from the phase 3 SELECT trial, in which the receptor tyrosine kinase inhibitor demonstrated a statistically significant progression-free survival (PFS) prolongation and response rate in patients with progressive, differentiated thyroid cancer who had become refractory to radioactive iodine (RAI) therapy. In the trial, median PFS was 18.3 months in the lenvatinib arm and 3.6 months in the placebo arm; and objective response rates (ORR) were 65% and 2% in the lenvatinib and placebo arms, respectively.

February 05,2015 Pfizer Inc. Ibrance™ (palbociclib)

On Feb. 3, 2015 the FDA granted accelerated approval to Pfizer’s cyclin-dependent kinase (CDK) inhibitor Ibrance (palbociclib) as a first-line treatment for women with ER+, HER2- locally advanced or metastatic breast cancer, several months ahead of its Apr. 13, 2015 PDUFA date. The approval was based on the results of the phase 2 PALOMA-1 trial. The study met its primary endpoint, with palbociclib and letrozole combined significantly prolonging progression-free survival (PFS) compared with letrozole alone in post-menopausal women with ER+, HER2- metastatic breast cancer. The approval is Ibrance's first in any market worldwide.

January 08,2015 Novartis/Sandoz Zarxio™ (filgrastim, EP2006)

The Oncologic Drugs Advisory Committee (ODAC) unanimously backed the approval of Novartis/Sandoz's copy of Amgen's blockbuster cancer drug Neupogen, setting the stage for the FDA's first U.S. approval of a biosimilar; the FDA advisory panel also voted in favor of approval of the biosimilar in all of the Amgen drug's indications.

2014

Date Company Product Event
December 22,2014 Bristol-Myers Squibb Opdivo (nivolumab)

On Dec. 22, 2014, the FDA granted accelerated approval to Opdivo (nivolumab) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

December 19,2014 AstraZeneca Pharmaceuticals Lynparza™ (olaparib)

On Dec. 19, 2014, the FDA approved Lynparza (olaparib) capsules as monotherapy for the treatment of patients with deleterious or suspected deleterious germline BRCA mutated (gBRCAm) (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

December 12,2014 Eli Lilly and Co. Cyramza® (ramucirumab)

On Dec. 12, 2014, the FDA approved Cyramza® Injection (ramucirumab), in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy.

December 09,2014 Sunesis Pharmaceuticals vosaroxin

Results from the phase 3 VALOR trial of vosaroxin and cytarabine in patients with relapsed or refractory acute myeloid leukemia (AML) will be presented in a late-breaking oral presentation at ASH (abstract LBA-6).

December 08,2014 Seattle Genetics Adcetris® (brentuximab vedotin)

One of the highlights of the ASH meeting will be an oral presentation of phase 3 results from the multinational AETHERA trial testing brentuximab vedotin as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in Hodgkin lymphoma (HL) patients at risk of relapse (abstract #673).

December 04,2014 Incyte Corp. Jakafi® (ruxolitinib)

On Dec. 4, 2014, the FDA approved Jakafi (ruxolitinib) for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea (HU).

December 03,2014 Amgen Blincyto™ (blinatumomab)

On Dec. 3, 2014, the FDA granted accelerated approval for Blincyto (blinatumomab) for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R ALL).

October 31,2014 Seattle Genetics / Takeda Adcetris® (brentuximab vedotin)

Seattle Genetics said in its July 31, 2014 second quarter earnings report that it plans to report Adcetris phase 3 AETHERA top-line clinical trial data by Oct. 2014. The AETHERA trial is evaluating Adcetris for Hodgkin lymphoma (HL) patients at risk of relapse following autologous stem cell transplant (ASCT).

October 30,2014 Amgen Trebananib

Phase 3 data is expected for trebananib in recurrent ovarian cancer.

October 18,2014 Incyte Jakafi® (ruxolitinib)

RELIEF, an ongoing phase 3 trial, is evaluating disease-related symptoms in patients with polycythemia vera (PV). If the trial results are positive, they are expected to be submitted to support labeling claims regarding the symptomatic benefit of ruxolitinib in PV. Data from the trial is due in mid-2014.

October 17,2014 Roche / ImmunoGen Kadcyla® (ado-trastuzumab emtansine)

Roche expects results from its MARIANNE phase 3 registration trial, evaluating Kadcyla as a first-line treatment for HER2-positive metastatic breast cancer, to be reported later this year. If the results are positive, the company plans to seek regulatory approval in 2015.

October 16,2014 Navidea Biopharmaceuticals Lymphoseek® (technetium Tc 99m tilmanocept) Injection

Navidea announced on Mar. 5, 2014 that the FDA had accepted for review a supplementary New Drug Application (sNDA) for a proposed expanded label for Lymphoseek "to support broader and more flexible use in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other optimization capabilities." The PDUFA review date is Oct. 16, 2014.

October 06,2014 Sunesis Pharmaceuticals vosaroxin (trademark name Qinprezo™)

Sunesis announced on Oct. 6, 2014 that, in the pivotal phase 3 VALOR trial, the combination of vosaroxin plus the cheomotherapy drug cytarabine in first relapsed or refractory acute myeloid leukemia (AML) did not lead to a statistically significant improvement in overall survival (OS), the study's primary endpoint. The trial data, however, did show a clinically significant benefit in complete remission rates, a secondary goal of the study. The company said it would meet with the FDA to determine its next steps in the regulatory process and would also seek marketing approval in Europe.

September 30,2014 ERYTECH Pharma ERY-ASP/GRASPA®

At an Investor R&D Day on Jan. 27, 2013, the company reported that its phase 3 study of ERY-ASP/GRASPA® in relapsing acute lymphoblastic leukemia (ALL) patients had completed patient enrollment in Aug. 2013 and was on track for a data read-out at the end of Q3 2014.

September 15,2014 Threshold Pharmaceuticals / Merck KGaA TH-302

TH-302, an investigational hypoxia-targeted drug, is currently being tested in two pivotal phase 3 trials: one (TH-CR-406) in combination with doxorubicin vs. doxorubicin alone in soft tissue sarcoma, and the other (MAESTRO) in combination with gemcitabine vs. gemcitabine and placebo in advanced pancreatic cancer (MAESTRO). The primary endpoint of both trials is overall survival (OS). The company said a pre-planned interim efficacy and safety analyses will be conducted by the trial's independent data monitoring committee (IDMC) in September, accompanied by a recommendation on next steps. A third large randomized phase 3 trial of TH-302 is designed to support registration in patients with advanced non-squamous non-small cell lung cancer (NSCLC). TH-302 is also being investigated in earlier stage trials for other solid tumor types and hematological malignancies.

September 11,2014 Astellas Pharma / Medivation Xtandi® (enzalutamide) capsules

Xtandi was approved on Sept. 10, 2014 by the FDA for use in “pre-chemo metastatic castration-resistant prostate cancer (mCRPC)" a few days ahead of its PDUFA date (Sept. 18, 2014). The sNDA had been granted a Priority Review. Xtandi is already approved for patients with mCRPC who have previously received docetaxel chemotherapy. The approval was based on data from the phase 3 PREVAIL trial.

September 04,2014 Merck Keytruda® (pembrolizumab)

Merck's pembrolizumab (which will be marketed as Keytruda) won accelerated approval from the FDA on Sept. 4, 2014 for unresectable or metastatic melanoma in patients previously treated with ipilimumab. The approval made the drug the first in its class of anti-PD-1 antibodies to be approved in the U.S., beating out its chief competitor, Bristol-Myers Squibb, in a tight race to get the first such immunotherapy to market here. The indication was approved under accelerated approval based on tumor response rate and durability of response and came ahead of the Oct. 28, 2014 PDUFA date. Keytruda had been designated by the FDA as a Breakthrough Therapy for advanced melanoma.

September 03,2014 Exelixis Cometriq® (cabozantinib, formerly XL184)

Exelixis on Sept. 1 reported topline results from the pivotal COMET-1 trial and said the study did not meet its primary endpoint of improving overall survival (OS). The trial tested cabozantinib versus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) who had previously been treated with docetaxel, in addition to Zytiga (abiraterone) and/or Xtandi (enzalutamide). The median OS for the cabozantinib arm was 11.0 months versus 9.8 months for prednisone arm; median progression-free survival (PFS) was 5.5 months for cabo versus 2.8 months for prednisone. Exelixis said it would also halt enrollment in a second pivotal trial (COMET-2) of mCRPC focused on pain relief. The company also said it would slash its workforce by 70% and focus on late-stage trials of cabozantinib in kidney and liver cancer, due to read-out in 2015 and 2017, respectively. (Cabozantinib - marketed as Cometriq - is already approved by the FDA as a treatment for a rare type of thyroid cancer.)

August 15,2014 Roche / Genentech Avastin® (bevacizumab)

The FDA approved Roche's Avastin plus chemotherapy for the treatment of recurrent platinum-resistant cervical cancer on Aug. 15, 2014 several months ahead of the PDUFA action date of Oct. 24, 2014 (the sBLA had been granted a Priority Review by the agency). The approval was based on data from the phase 3 GOG-0240 study which showed that there was a 26% reduction in the risk of death for women who received Avastin plus chemotherapy compared to women who received chemo alone. Women who received Avastin plus chemotherapy also had a significantly higher rate of tumor shrinkage (objective response rate, ORR) compared to chemo alone (45% vs. 34%). Avastin is now approved in the U.S. for five distinct tumour types.

August 13,2014 Amgen / Onyx Kyprolis® (carfilzomib)

On Aug. 13, 2014 Amgen reported that the FOCUS phase 3 study, which compared Kyprolis to best supportive care in relapsed/refractory multiple myeloma (MM) patients, did not meet its primary endpoint of overall survival. The company said that the recent positive ASPIRE data (see separate Radar item dated Aug. 4, 2014), another phase 3 trial of Kyprolis in MM that had met its primary endpoint of progression-free survival, would support regulatory submissions globally for the drug. Detailed results from FOCUS will be submitted for presentation at a future medical meeting, Amgen said.

August 11,2014 Exact Sciences Corp. Cologuard®

On Aug. 11, 2014, the FDA approved Exact Sciences' Cologuard, a non-invasive DNA test to screen for colon cancer in people with a lower risk of developing the disease, the first test of its kind to be cleared by U.S. regulators. Cologuard detects genetic mutations in patients' stool associated with cancerous and precancerous growths in the colon and patients can collect stool samples at after a doctor has prescribed the test. In a large clinical trial of over 10,000, Cologuard identified more cancers than a competing blood test. At the same time as the FDA approval, the CMS also issued a proposed national coverage determination for Cologuard, making it the first product to be reviewed through a joint FDA-CMS pilot program intended to speed up the time between FDA approval and obtaining CMS coverage for a medical device. In Mar. 2014, an FDA advisory committee voted unanimously (10 to 0) in favor of Cologuard's approval.

August 05,2014 Amgen / Onyx Pharmaceuticals Kyprolis® (carfilzomib) for Injection

The company on Aug. 4, 2014 said that the phase 3 ASPIRE study, evaluating the addition of Kyprolis to Revlimid (lenalidomide) and low-dose dexamethasone in "first relapse" MM patients, had met its primary endpoint of progression-free survival (PFS). The interim analysis showed that patients treated with Kyprolis helped patients live 8.7 months longer without their disease worsening. ASPIRE is designed to confirm the accelerated approval of Kyprolis in the U.S. and to support the drug's approval in Europe. The company plans to submit the study's results for presentation at the upcoming ASH meeting being held in December.

July 25,2014 Gilead Inc. Zydelig (idelalisib)

On Jul. 23rd, the FDA approved Gilead's idelalisib, which will be marketed as Zydelig, to treat three types of blood cancer. The drug received a traditional approval for use in combination with Roche's Rituxan for patients with relapsed chronic lymphocytic leukemia (CLL). The agency also gave the drug an accelerated approval for patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL) who have received at least two prior therapies.

July 24,2014 Puma Biotechnology neratinib (PB272) Puma announced positive top line results from a late-stage trial of neratinib. In the phase 3 ExteNET study, patients with early stage HER2-positive breast cancer, who received neratinib for a year following surgery and treatment with Herceptin, showed a 33% improvement in disease-free survival compared with those on a placebo. In extended trading on Jul. 22nd the company's stock more than tripled. Based on the study's results, the company plans to file for regulatory approval of neratinib as an extended adjuvant therapy in the first half of 2015. Full results from the trial will be presented at an upcoming medical meeting.
July 03,2014 Spectrum Pharmaceuticals / Topotarget Beleodaq™ (belinostat) for Injection

The FDA granted Accelerated Approval of Spectrum's Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) on July 3, 2014, nearly 5 weeks before the PDUFA date (Aug. 9, 2014). The FDA accelerated approval was based on Tumor Response Rate and Duration of Response from the BELIEF trial. It was the company's second approval for a treatment for R/R PTCL - Folotyn® (pralatrexate injection) was its first approved drug.

June 16,2014 Navidea Biopharmaceuticals Lymphoseek® (technetium Tc 99m tilmanocept) Injection

The company said on Feb. 18 that the FDA had accepted its Supplemental New Drug Application (sNDA) for Lymphoseek and granted a Priority Review for an expanded indication for sentinel lymph node (SLN) detection in patients with head and neck cancer. The PDUFA date for the Lymphoseek sNDA is June 16, 2014. The radiopharmaceutical was approved in March 2013 for use in lymphatic mapping procedures that are performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor for patients with breast cancer and melanoma.

April 30,2014 Novartis AG Zykadia™ (ceritinib, previously known as LDK378)

On Apr. 29, 2014, the FDA approved Zykadia™ (ceritinib) for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. The new oral ALK inhibitor's accelerated approval was based on a pivotal trial demonstrating an overall response rate (ORR) of 54.6% in patients with ALK+ metastatic NSCLC with no other treatment option and a median duration of response to certinib of 7.4 months. U.S. regulators had previously designated ceritinib as a Breakthrough Therapy and approved the drug four months ahead of schedule.

April 29,2014 OncoGenex Pharmaceuticals / Teva custirsen

The companies announced top-line survival results from the pivotal SYNERGY phase 3 trial on Apr. 28, 2014. In the trial, the addition of custirsen to standard first-line docetaxel/prednisone therapy did not meet the primary endpoint of a statistically significant improvement in overall survival (OS) in men with metastatic castrate-resistant prostate cancer (CRPC) compared to docetaxel/prednisone alone (median survival 23.4 months vs 22.2 months, respectively). The companies said that full efficacy and safety data from SYNERGY would be submitted for presentation at an upcoming medical conference. Custirsen had received FDA Fast Track designation for three phase 3 trials including SYNERGY, the phase 3 AFFINITY second-line metastatic CRPC trial, and the phase 3 ENSPIRIT metastatic non-small cell lung cancer trial.

April 24,2014 Janssen Biotech Sylvant™ (siltuximab)

The FDA approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes). Sylvant is the first FDA-approved drug to treat patients with MCD. Administered as an injection, Sylvant is intended for patients with MCD who do not have HIV or human herpes virus 8 (HHV-8). The FDA reviewed the drug under its priority review program and also granted Sylvant orphan product designation since it treats a rare disease or condition.

April 21,2014 Eli Lilly and Company Cyramza™ (ramucirumab)

The FDA approved ramucirumab for use as a single agent for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy.

April 17,2014 GlaxoSmithKline Arzerra® (ofatumumab)

The FDA approved ofatumumab (Arzerra® Injection, for intravenous infusion) in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate.

March 20,2014 GlaxoSmithKline and Agenus MAGE-A3 cancer vaccine

The companies announced on Mar. 20th that the phase 3 MAGRIT trial, testing the MAGE-A3 cancer vaccine in non-small cell lung cancer (NSCLC) patients, did not meet its first or second co-primary endpoint, failing to significantly extend disease-free survival compared to placebo in either the overall MAGE-A3 positive population (first co-primary endpoint) or in MAGE-A3-positive patients who did not receive chemotherapy (second co-primary endpoint). GSK plans to continue the trial to assess a third co-primary endpoint designed to identify a subset of MAGE-A3 positive patients that may benefit from treatment. Final results are expected in 2015.

March 12,2014 Bayer / Onyx Pharmaceuticals Nexavar® (sorafenib)

A late-stage trial testing Nexavar as an adjuvant therapy for patients with liver cancer, failed to meet its primary endpoint of improving recurrence-free survival, the companies said on Mar. 11th. The phase 3 trial, dubbed STORM, evaluated Nexavar versus placebo as an adjuvant treatment in patients with hepatocellular carcinoma (HCC) following potential curative treatment (surgical resection or local ablation). Sorafenib is already approved for unsectable liver cancer, kidney and thyroid cancer. Data from the study will be submitted for presentation at an upcoming medical meeting.

March 08,2014 Novartis / Incyte Jakafi® (ruxolitinib)

On Mar. 7th the companies announced positive topline results from the pivotal phase 3 RESPONSE trial of ruxolitinib compared to best available therapy in patients with polycythemia vera (PV) resistant to or intolerant of hydroxyurea. The trial met its primary endpoint of achieving phlebotomy independence and reducing spleen size by 35% or more. Ruxolitinib is the first selective JAK1/JAK2 inhibitor to demonstrate efficacy in a phase 3 trial for treating PV. Data will be presented at an upcoming scientific meeting; the companies also plan to submit a sNDA to the FDA this year.

February 21,2014 Onconova Therapeutics Inc. rigosertib

Onconova reported topline results from the pivotal phase 3 ONTIME trial of intravenous (IV) rigosertib in patients with higher risk myelodysplastic syndromes (MDS) after prior therapy with hypomethylating agents (HMAs) and said that the study had failed to meet its primary endpoint of overall survival compared to best supportive care (BSC). The company also said that a post-hoc analysis showed a statistically significant increase in median overall survival for a subset of MDS patients in the study (i.e., those who had not responded to HMAs) and they would discuss the data further with U.S. and European regulators. An additional analysis of the data will be presented at ASCO 2014, Onconova said.

February 19,2014 Eli Lilly & Co. Ramucirumab (IMC-1121B)

Lilly announced positive results from the pivotal phase 3 Revel trial testing ramucirumab and chemotherapy (docetaxel) against a placebo and docetaxel in patients with non-small cell lung cancer. The experimental cancer therapy significantly improved overall survival rates for patients in the trial as well as improving survival rates without the cancer worsening. While ramucirumab failed to delay the progression of breast cancer in a late-stage trial last year, it has shown success in stomach cancer trials; the company is awaiting an FDA decision later this year for that indication. Lilly said that the data from Revel would be presented at an upcoming medical meeting.

February 13,2014 Pharmacyclics / Janssen Biotech (Johnson & Johnson) Imbruvica™ (ibrutinib)

On Feb. 12, 2014 the FDA expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy. The new indication follows ibrutinib's approval on Nov. 13, 2013 for previously treated mantle cell lymphoma (MCL). Both the approved indications are based on the drug's overall response rate (ORR). In a study of 48 previously treated CLL patients, nearly 58% of participants had their cancer shrink after treatment (ORR). Imbruvica is one of the first medicines to file for FDA approval via the new Breakthrough Therapy Designation pathway, allowing Pharmacyclics to rapidly bring this medicine to patients in need.

January 10,2014 GlaxoSmithKline plc Mekinist® (trametinib) and Tafinlar® (dabrafenib)

On Jan. 8, 2014, GSK won accelerated approval from the FDA after a Priority Review for the first combination of oral targeted therapies, Mekinist (trametinib) and Tafinlar (dabrafenib), for patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA approved test. Both drugs are already approved for separate use but the company believes they will have a longer-lasting effect if given together. GSK hopes that the newly approved combination will become part of the new standard of care for appropriate patients with BRAF V600E or V600K mutation-positive metastatic melanoma. The approval is based on data from a phase 1/2 study demonstrating response rate and median duration of response. Progression-free survival or overall survival has not been demonstrated for Mekinist in combination with Tafinlar. The FDA's accelerated approval is contingent on the results of an ongoing phase 3 trial, designed to evaluate the clinical benefit of the combination in this patient population.

2013

Date Company Product Event
December 31,2013 Exelixis Cabozantinib

Exelixis is expected to report results from an interim analysis of the pivotal phase 3 COMET-1 trial of cabozantinib in patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with docetaxel, abiraterone acetate and/or enzalutamide before the end of this year. The primary endpoint of the trial is overall survival; the study's secondary endpoint is bone scan response. Top-line data from COMET-1 and a second pivotal trial in mCRPC, COMET-2, is expected in 2014. Cabozantinib (Cometriq®) is currently approved for progressive, metastatic medullary thyroid cancer (MTC) and phase 2 studies in prostate cancer have been positive.

December 25,2013 Bayer HealthCare / Onyx Pharmaceuticals (Amgen) Nexavar® (sorafenib) tablets

Bayer and Onyx announced on Aug. 27 that the FDA had granted Priority Review designation to the supplemental New Drug Application (sNDA) for Nexavar, under evaluation for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. The PDUFA date for an FDA decision on the additional indication for the drug is December 25, 2013.

December 10,2013 Gilead Sciences Idelalisib

Detailed study results from Gilead's phase 3 trial (Study 116) of idelalisib in combination with rituximab in previously-treated chronic lymphocytic leukemia (CLL) patients who were not candidates for chemotherapy will be presented as a late-breaking abstract (Abstract #LBA-6) at ASH on Dec. 10, 2013. Study 116 was stopped early in Oct. '13 when it showed "a highly statistically significant effect on the primary endpoint of progression-free survival (PFS)" and also met secondary endpoints of overall response, lymph node response and overall survival. The FDA granted idelalisib a Breakthrough Therapy designation for CLL in relapsed patients based on results from the study, and the trial's data is also the basis for plans for regulatory filings for idelalisib in the U.S. and European Union.

December 09,2013 Geron Corp. Imetelstat

Geron’s stock doubled in morning trading on Nov. 7 as data released online in advance of ASH's annual meeting showed that the company's drug imetelstat’s "mechanism of action" was effective in patients with high-risk or intermediate-2 risk myelofibrosis (MF). The data suggested that imetelstat was superior to Incyte's Jakafi (ruxolitinib), another drug already approved to treat MF, and might be active in modifying the disease rather than simply providing symptomatic relief to patients, as is the case with other currently approved therapies. Updated results from the phase 2 trial, whose primary endpoint is overall response rate, will be presented in an oral session on Monday, Dec. 9, at 4:45 pm CST at ASH.

December 08,2013 Genentech (Roche) Gazyva™ (obinutuzumab) also known as GA101

In Stage 2 data from the phase 3 CLL11 study comparing Gazya plus chlorambucil with Roche's older drug, Rituxan® (rituximab), plus chlorambucil in people with previously untreated chronic lymphocytic leukemia (CLL), people treated with Gazyva lived nearly a year longer without their disease worsening (progression-free survival, or PFS). For patients in the Gazyva arm, median PFS was 26.7 mos. compared with 15.2 mos. for those taking Rituxan. Full CLL11 study results, including an updated analysis from Stage 1a of the CLL11 study, which compared Gazyva in combination with chlorambucil to chlorambucil alone, will be presented during the Plenary Scientific Session at ASH on Sunday, Dec. 8.

December 08,2013 Onconova Therapeutics Rigosertib

The company is expected to release top-line results from a phase 3 study of rigosertib in high-risk patients with myelodysplastic syndrome (MDS) in December '13 or the beginning of 2014. Meanwhile, at ASH, Onconova will present data on the efficacy, tolerability, and dosing regimen from the phase 2 (ONTARGET) study of oral rigosertib in transfusion-dependent, lower risk MDS patients. The phase 2 results at ASH are anticipated by some analysts to set the stage for reporting further positive outcomes in the late-stage, pivotal phase 3 trial in high-risk patients which are due later on.

December 08,2013 Celgene Corp. Revlimid® (lenalidomide)

Initial data from the phase 3 FIRST study of Revlimid in combination with dexamethasone in patients newly diagnosed with multiple myeloma (NDMM) who are ineligible for stem cell transplantation will be presented during the plenary session at ASH on Dec. 8, 2013. The primary endpoint of the three-arm trial is a comparison of progression-free survival (PFS) in Arm A vs. Arm C.

November 22,2013 Bayer HealthCare / Onyx Pharmaceuticals (Amgen) Nexavar® (sorafenib)

On Nov. 22 the FDA approved a new indication for Nexavar as a treatment for metastatic differentiated thyroid carcinoma that is refractory to radioactive iodine treatment, making the drug the first and only FDA-approved treatment option for patients with this type of thyroid cancer. The approval follows a priority review by the FDA for the oral multi-kinase inhibitor and is based on data from the phase 3 DECISION trial which showed that Nexavar extended progression-free survival by 41% compared to placebo (10.8 months versus 5.8 months). Sorafenib is already approved to treat kidney and liver cancer.

November 13,2013 Pharmacyclics / Janssen Biotech (Johnson & Johnson) Imbruvica™ (ibrutinib)

After a priority review and well ahead of its Feb. 28, 2014 PDUFA date, the FDA approved Imbruvica™ (ibrutinib) as a single agent for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Imbruvica, an oral therapy and a BTK inhibitor, is the second drug with a "Breakthrough Therapy" designation from the FDA to win approval. The indication is based on overall response rate (ORR); an improvement in survival or disease-related symptoms has not been established.

November 01,2013 Roche Holding AG / Genentech Gazyva™ (obinutuzumab), also known as GA101

The FDA approved Roche/Genentech's Gazyva (obinutuzumab) for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL) in combination with chemotherapy (chlorambucil). Gazyva is the first medicine approved with the FDA’s "Breakthrough Therapy" Designation. The approval is based on the outcomes of the pivotal phase 3 CLL11 trial which showed that people who received Gazyva in combination with chlorambucil had significantly reduced risk of disease progression or death and lived significantly longer without their disease worsening compared to those who received chlorambucil alone (median PFS 23.0 mos. vs. 11.1 mos.). The approval came well before the Dec. 20, 2013 date when the FDA was to decide whether or not to green light the drug. A marketing application has also been filed in Europe for obinutuzumab.

October 22,2013 Medivation / Astellas Xtandi® (enzalutamide)

The phase 3 PREVAIL study of Xtandi in chemotherapy-naïve patients with advanced prostate cancer was stopped early after meeting its co-primary endpoints. Based on an interim analysis of PREVAIL, patients treated with Xtandi had a 30% reduction in the risk of death compared to patients treated with placebo, more than the 21% survival benefit shown by Johnson & Johnson's competing prostate cancer drug, Zytiga, in a similar phase 3 trial. Based on the positive findings, an independent committee also recommended offering Xtandi to patients who were in the placebo arm of the trial. Xtandi won approval in Aug. 2012 for advanced prostate cancer that no longer responds to chemotherapy. The companies will now seek FDA and European approval to expand the drug's use to treat men with advanced prostate cancer who have not yet received chemotherapy or "pre-chemo." Additional data from the trial will be submitted for presentation at an upcoming medical conference, the companies said.

September 30,2013 Roche / Genentech Perjeta® (pertuzumab) injection

Roche/Genentech’s Perjeta won accelerated approved from the FDA on Sept. 30, 2013, making it the first drug ever approved to treat breast cancer before surgery. Perjeta was approved for women with HER2+ early-stage breast cancer who have a high risk of the cancer spreading to other parts of the body. The approval was based on a 417-woman study comparing Perjeta in different combinations against older breast cancer treatments. In that phase 2 study, women who received pertuzumab as an initial treatment were more likely to be cancer-free 12 weeks later than women who received older drug combinations. Genentech must now conduct a larger follow-up study showing the drug’s long-term benefits for patients, which generally means showing that patients have lived longer or have had a higher quality of life due to treatment with the drug. Results from the follow-up study are expected in 2016. Perjeta’s new indication calls for its use in combination with Herceptin and the chemotherapy drug docetaxel.

September 13,2013 Delcath Systems proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System)

Delcath announced on Sept. 13 that the FDA had issued a complete response letter (CRL) and rejected its drug-device system for treating patients with a rare form of eye cancer that has spread to the liver. U.S. regulators said they wanted another clinical trial showing that the treatment is safe and effective based on overall survival, and that its benefits outweigh its risks. The rejection was anticipated and came four months after an FDA Advisory Committee voted against recommending the Melblez Kit's approval.

September 06,2013 Celgene Corp. Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)

After a Priority Review, Celgene's drug Abraxane was approved by the FDA on Sept. 6 as a first-line treatment for patients with advanced pancreatic cancer, slightly ahead of its Sept. 21, 2013 PDUFA date. In the phase 3 MPACT trial, patients with metastatic pancreatic cancer treated with Abraxane plus the chemotherapy gemcitabine had a statistically significant improvement in overall survival compared with those treated with gemcitabine alone (median of 8.5 vs. 6.7 months). Celgene has plans to develop a phase 3 study of Abraxane plus gemcitabine in the adjuvant pancreatic cancer setting.

August 20,2013 GTx enobosarm

GTx stock plunged nearly 70% on August 19 as the company reported disappointing results from two phase 3 trials (POWER1 and POWER2) of enobosarm, its experimental muscle wasting drug, in patients with non-small cell lung cancer (NSCLC) combined with chemotherapy. The treatment failed to meet its dual goals of increasing lean body mass and improving physical function in cancer patients in the studies. The company said that the drug did have an impact on lean body mass in one of the two studies compared with patients who received a placebo. CEO Mitchell Steiner said the company was confident the drug would provide a clinical benefit and possibly increase patient survival. Cowen & Co. analyst Eric Schmidt noted however that the FDA was clear that physical function would be a requirement for approval, and that increases in lean body mass were not accompanied by improvements in physical function or survival in either study. The company said it would meet with both U.S. and European regulators to discuss the next steps for enobosarm, which had been granted fast-track status by the FDA in January. It was the second successive lead drug to fail late-stage trials for GTx, which in 2010 discontinued the development of its lead prostate cancer drug.

August 12,2013 Vical Inc. Allovectin® (velimogene aliplasmid)

Vical said on August 12 that a late-stage trial of its melanoma immunotherapy, Allovectin, failed to show that the treatment was significantly better than chemotherapy. The company's shares fell 60%. Allovectin failed to meet the study’s primary endpoint—an objective response rate—in addition to the secondary endpoint of overall survival. Based on the trial's outcome, CEO Vijay Samant said the company was terminating the Allovectin program and would focus resources on its infectious disease vaccine programs. The company did not disclose any data from the trial but said it would release results at an upcoming medical conference.

July 12,2013 Boehringer Ingelheim Pharmaceuticals Gilotrif® (afatinib; BIBW 2992)

On July 12th, the FDA approved afatinib (which will be marketed as Gilotrif) for patients with EGFR-mutation positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. U.S. regulators also approved Qiagen NV's gene test to identify patients who will best respond to the medication. Gilotrif's approval is based on data from the pivotal LUX-Lung phase 3 trial in which afatinib demonstrated a significant delay in tumor growth vs. the best-in-class chemotherapy. Patients taking afatinib as a first-line treatment lived for almost one year without their tumour growing (PFS of 11.1 months) vs. just over half a year (PFS of 6.9 months) for those on chemotherapy (pemetrexed/cisplatin). U.S. regulators had assigned the drug a Priority Review and approved it a few days ahead of a July 15, 2013 action date.

June 13,2013 Amgen Xgeva® (denosumab)

on June 13, 2013, after a priority review, the FDA approved an additional use for Xgeva as a treatment for adults and skeletally mature adolescents with giant-cell tumor of the bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity. The expanded indication makes Xgeva the first and only treatment that U.S. regulators have approved for the rare and typically noncancerous tumor. The FDA initially approved the drug in 2010 for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors.

June 10,2013 AVEO Oncology tivozanib

On June 10, 2013, AVEO announced that the FDA had rejected its marketing application for tivozanib as a treatment for advanced renal cell carcinoma (RCC) and issued a Complete Response Letter. The FDA recommended an additional clinical study be conducted since they said the results of the TIVO-1 study on which the application was based were "uninterpretable and inconclusive" in drawing a risk-benefit conclusion necessary for approval. It was just another blow for the company and its potential kidney cancer drug, which in early May had also received a thumbs-down from an ODAC in a 13-1 vote. Aveo's partner Astellas Pharma also dropped its plans to file for marketing approval in Europe and said it wouldn't fund any more studies of tivozanib in RCC. Wall Street had anticipated the negative FDA decision on tivozanib, which came well ahead of the drug's July 28, 2013 PDUFA action date.

June 05,2013 Celgene Corp. Revlimid® (lenalidomide)

On June 5, 2013, the FDA approved another indication for Celgene's flagship blood cancer drug, Revlimid, as a treatment for patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which must include Velcade® (bortezomib). Revlimid is the first oral therapy approved for MCL. The drug is already approved to treat multiple myeloma and myelodysplastic syndromes.

May 29,2013 GlaxoSmithKline Tafinlar (dabrafenib) and Mekinist (trametinib)

On May 29, 2013 the FDA approved Tafinlar and Mekinist, both as single agents, for patients with advanced melanoma. Tafinlar, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors express the BRAF V600E gene mutation. Mekinist, a MEK inhibitor, is approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations. The FDA concurrently approved the THxID BRAF test, a companion diagnostic that will help determine if a patient’s melanoma cells have the V600E or V600K mutation in the BRAF gene. The action date for an approval decision on dabrafenib was June 3, 2013; trametinib's action date had been pushed back from June 3 to September 3, 2013 in order to give the agency more time to review additional manufacturing data from Glaxo.

May 15,2013 Bayer AG / Algeta ASA Xofigo (radium Ra 223 dichloride) injection

Bayer and partner Algeta won FDA approval on May 15, 2013 for their new injectable drug that uses radiation to treat an advanced prostate cancer that has spread to the bones. The FDA cleared Xofigo for men with symptomatic, late-stage, castration-resistant prostate cancer with metastases in bone but not other organs, following conventional medical and/or surgical therapy to reduce testosterone levels. The product was approved more than three months ahead of its PDUFA goal date of Aug. 14, 2013 under the agency’s priority review program. Patients on Xofigo in a clinical trial survived a median of 14 mos. compared with 11.2 mos. for men receiving a placebo plus best standard of care.

May 14,2013 Genentech / OSI Pharmaceuticals & Roche Molecular Systems Tarceva® (erlotinib) and the cobas EGFR Mutation Test

The FDA approved an expanded use for Tarceva on May 14, 2013 as a first-line treatment for patients with metastatic non-small cell cancer (NSCLC) who have certain mutations in the EGFR gene. U.S. regulators also approved the cobas EGFR Mutation Test, a companion diagnostic for Tarceva. The cobas EGFR Mutation Test is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations. The approval is Tarceva’s fourth indication and the third use for lung cancer.

May 02,2013 AVEO Oncology / Astellas Pharma tivozanib (proposed brand name Tivopath™)

In a 13 to 1 vote (with 0 abstentions), an FDA advisory panel voted against recommending that the agency approve AVEO and partner Astellas’ drug tivozanib as a treatment for patients with advanced renal cell carcinoma (RCC). Although a pivotal trial of 517 patients showed a trend toward progression free-survival for tivozanib, patients didn’t live longer than those on a rival treatment sorafenib (Onyx, Bayer’s Nexavar). Panelists said the trial results were inconsistent and didn't show a positive benefit-risk profile. There was also a 25% death risk for patients on tivozanib in the trial, the FDA’s Medical Officer pointed out. The company said the negative survival statistic was due to cross-over from one treatment (Nexavar) to the other (tivozanib) during the trial. Expert panelists also questioned the fact that AVEO's clinical trials were conducted mainly with a Central and Eastern Europe population rather than with U.S. patients. That was due to a lack of patients for enrollment since other RCC trials were simultaneously being conducted, the company said. AVEO’s trading was halted during the meeting, and resumed afterwards, with shares falling up to 57%. AVEO’s CEO said that the company “is confident in the efficacy, safety and tolerability of tivozanib in RCC patients” and that it would work closely with the FDA to address issues brought up in reviewing the drug’s NDA. The PDUFA action date for the drug is July 28, 2013.

May 02,2013 Delcath Systems proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System)

In a unanimous 16-0 vote, an FDA panel advised against the FDA's approving Delcath Systems's Melblez Kit, a drug/device combination product to treat ocular melanoma which has spread to the liver, saying it was too risky. While there's currently no approved therapy for patients with this rare type of eye cancer, the FDA staff said there was no indication the treatment improved overall survival or delayed disease progression. One adviser said during the meeting that patients' quality of life would be worse after the therapy. Delcath outlined a specific risk management strategy to reduce the risks of the procedure, but reviewers said that strategy could not be expected to eliminate its inherent toxicities. Delcath's shares have lost three-quarters of their value from their year-high of $2.94 in May. The PDUFA action date for Melblez is September 13, 2013.

April 19,2013 Exact Sciences Cologuard®

Although Exact's molecular screening test for colorectal cancer, Cologuard, met its main goals in a pivotal late-stage study, the company's shares fell as much as 30% on April 18 since the results weren't as robust as Wall Street had expected. The non-invasive test detected 92% of colorectal cancers and 42% of pre-cancerous polyps but, according to a Reuters report, the expectations for the detection of pre-cancerous polyps had been closer to 55%. Exact plans to submit the study data to the FDA as part of its approval application.

April 03,2013 Clavis Pharma ASA elacytarabine

The company suspended all development of an experimental leukemia treatment based on its Lipid Vector Technology and said it would close or seek buyers as elacytarabine failed in the phase 3 CLAVELA trial. The study didn’t show a significant difference in overall survival rates between patients with relapsed or refractory acute myeloid leukaemia (AML) who received elacytarabine and those on other treatments.

March 28,2013 A.P. Pharma APF530

U.S. regulators rejected for a second time the company's lead product candidate, APF530, a long-acting formulation of granisetron meant to prevent chemotherapy-induced nausea and vomiting (CINV). The FDA initially refused to approve the anti-nausea drug in March 2010. The agency issued a Complete Response Letter (CRL) with concerns about the syringe system used for APF530, a product quality test and the analysis of data from a phase 3 clinical trial. The company expressed confidence that it could address those issues and pushed back its timetable for the product's launch from 2H 2013 to 1H 2014. AP Pharma's stock hasn't traded above $1 since April 2010.

March 27,2013 ZIOPHARM Oncology palifosfamide (ZIO-201)

ZIOPHARM’s shares fell 66% as the company said that the phase 3 PICASSO study of palifosfamide, combined with doxorubicin, in first-line metastatic soft tissue sarcoma failed to meet its primary endpoint of improving progression-free survival (PFS). An independent committee recommended that the patients in the study be followed for overall survival data, but Ziopharm said it did not expect to continue the follow-up. The company said it would terminate any further development of palifosfamide and would instead focus on the pipeline for its synthetic biology program. Palifosfamide was also being studied in a late-stage trial of first-line metastatic small cell lung cancer--the company said that trial would be converted to a mid-stage trial.

March 13,2013 Navidea Biopharmaceuticals Lymphoseek® (technetium Tc 99m tilmanocept) Injection

The FDA approved Lymphoseek, a radioactive diagnostic imaging agent, to help doctors locate lymph nodes in patients with breast cancer or melanoma undergoing surgery. The imaging drug is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is the first new drug used for lymph node mapping to be approved in more than 30 years, the FDA said. The company resubmitted its marketing application in Oct. 2012 after the agency declined earlier to approve it due to issues with a third-party manufacturer. Lymphoseek was approved more than a month ahead of its April 30, 2013 PDUFA date.

March 11,2013 Aeterna Zentaris perifosine

Shares of Aeterna Zentaris fell as much as 29 percent on March 11 with disappointing news about a late-stage trial in multiple myeloma. The company said it would discontinue its phase 3 trial of perifosine in combination with bortezomib (Velcade®) and dexamethasone in relapsed/refractory multiple myeloma based on an independent Data Safety Monitoring Board's (DSMB) recommendation. In a pre-planned interim analysis of safety and efficacy, the DSMB said it was highly unlikely the study would achieve a significant difference in its primary endpoint, progression-free survival (PFS), when perifosine plus the combo was compared to placebo.

February 25,2013 Bayer HealthCare / Onyx Pharmaceuticals Stivarga® (regorafenib) tablets

On Feb. 25th, the FDA approved a new indication for Bayer and Onyx's colon cancer drug, Stivarga, as a treatment for patients with advanced gastrointestinal stromal tumors (GIST) which cannot be surgically removed and which no longer respond to other FDA-approved treatments, Novartis' Gleevec and Pfizer's Sutent. The approval is based on a phase 3 trial of 199 patients who had been previously treated with Gleevec or Sutent. Two-thirds of patients were given Stivarga while one-third were given a placebo drug. Results presented last June at ASCO showed that Stivarga improved progression-free survival (PFS) with patients on regorafenib living 4.8 months without their disease worsening, compared with 0.9 months for patients on placebo.

February 25,2013 Merck KGaA / EMD Serono cilengitide

Merck KGaA said its potential treatment for brain cancer, cilengitide, failed to meet its primary endpoint in a phase 3 trial. The trial, called CENTRIC, missed its goal of significantly increasing patients’ overall survival (OS), when added to the current standard of care, chemoradiotherapy. The study included patients with newly diagnosed glioblastoma who had a certain genetic mutation. The company said it would analyze the data from the trial in the coming months with appropriate disclosure.

February 23,2013 Roche/Genentech and ImmunoGen Kadcyla™ (ado-trastuzumab emtansine or T-DM1)

On Feb. 22nd the FDA approves Roche/Genentech’s Kadcyla (formerly dubbed T-DM1) for the treatment of people with HER2-positive metastatic breast cancer who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. In the phase 3 EMILIA study, patients taking Kadcyla survived an average of 30.9 months, compared with 25.1 months in the control group. The drug's label will carry a boxed warning on its potential to cause liver and heart toxicity and death, in addition to life-threatening birth defects. U.S. regulators approved the cancer therapy a few days ahead of its Feb. 26 PDUFA date after a priority review.

February 08,2013 Celgene Corp. Pomalyst® capsules (pomalidomide)

On Feb. 8th, the FDA granted accelerated approval to Pomalyst for patients with multiple myeloma whose disease has worsened after being treated with at least two cancer drugs, including Revlimid (lenalidomide) and Velcade (bortezomib), and who have demonstrated disease progression on or within 60 days of completion of the last therapy. The therapy is the second cancer drug for multiple myeloma to win accelerated approval in the last seven months. Pomalyst's label will carry a "boxed warning" saying that the drug should not be given to pregnant women due to the danger of life-threatening birth defects, and that it can cause blood clots. Celgene’s application was based on the phase 2 (MM-002) trial in which patients either took pomalidomide, plus a low dose of the standard treatment dexamethasone, or pomalidomide alone. Results showed that median progression-free survival was 4.7 months in the pomalidomide plus dexamethasone arm, versus 2.7 months in the pomalidomide-alone arm.

January 30,2013 Roche / Genentech obinutuzumab (GA101)

On Jan. 30th, the companies announced that the first stage of a phase 3 study of obinutuzumab (GA101) had met its primary endpoint. In the CLL11 study, obinutuzumab (GA101) plus chlorambucil, a chemotherapy, significantly improved progression-free survival in people with previously untreated chronic lymphocytic leukemia (CLL) compared to chlorambucil alone. The companies also said that an additional futility analysis suggested that GA101 could show superiority compared to MabThera/Rituxan in first line CLL. Data from CLL11, a three-arm study comparing GA101 plus chlorambucil to MabThera/Rituxan plus chlorambucil or chlorambucil alone, will be submitted for presentation at an upcoming medical meeting and will also be submitted to European and U.S. regulators for potential approval.

January 23,2013 Genentech / Roche Avastin® (bevacizumab)

Slightly ahead of its Feb. 5th target date, the FDA approved Genentech's supplemental Biologics License Application (sBLA), expanding Avastin's label in metastatic colorectal cancer. The new indication is for Avastin’s use with fluoropyrimidine-based (5-FU-based) chemotherapy as a second-line treatment for patients with metastatic colorectal cancer (mCRC) who have progressed on a first-line Avastin-containing regimen. Avastin is already approved in combination with chemotherapy for people with mCRC as a first-line treatment or as a second-line treatment for people whose cancer has worsened following initial treatment with chemotherapy only. The new approval is based on results of the ML18147 study, the first and only prospective phase 3 study to comprehensively evaluate continually inhibiting VEGF as a potential treatment strategy for mCRC.

January 23,2013 Celgene Corp. Abraxane® (paclitaxel)

Celgene reported that treatment-naive patients with advanced pancreatic cancer who took Abraxane plus the chemotherapy agent gemcitabine lived an average of two months longer than those taking gemcitabine alone (median of 8.5 vs. 6.7 months) in the phase 3 MPACT trial. After one year, 35% of patients taking Abraxane were alive, compared with 22% of those on gemcitabine alone; after two years, the figures were 9% for the Abraxane arm compared to 4% for those on gemcitabine. Abraxane also improved progression-free survival for patients, a secondary endpoint of the trial. The company reported detailed results on January 22nd ahead of a late-breaking oral presentation scheduled for Friday, January 25th at the ASCO Gastrointestinal Cancers Symposium in San Francisco. The company said it would file for approval of the drug as a treatment for advanced pancreatic cancer in the first half of 2013.

January 03,2013 Bayer HealthCare / Onyx Pharmaceuticals Nexavar® (sorafenib) tablets

The phase 3 DECISION trial of Nexavar in patients with locally advanced or metastatic radioactive iodine-refractory (RAI) differentiated thyroid cancer met its primary endpoint and showed a statistically significant improvement in progression-free survival, the companies announced on Jan. 3. The companies anticipate a regulatory submission for sorafenib in the indication and said they would present the trial data at an upcoming medical meeting.

2012

Date Company Product Event
December 14,2012 ARIAD Pharmaceuticals Iclusig™ (ponatinib)

After a priority review, ARIAD's Iclusig (ponatinib) was approved by the FDA on Dec. 14, 2012, more than three months before its targeted action date of March 27, 2013, for two rare types of leukemia. The once-daily pill was approved for patients with chronic myeloid leukemia (CML) or Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy, which includes second-generation TKIs Sprycel and Tasigna. ARIAD's stock fell 21% on the same day as its approval--its label includes a black box warning on the dangers of liver toxicity and blood clots. The company's first marketed therapy won't come cheaply either--Iclusig will wholesale for about $115,000 a year.

November 29,2012 Exelixis Cometriq™(cabozantinib, XL184)

On Nov. 29th, the FDA approved Exelixis’ cabozantinib (brand name Cometriq) as a treatment for progressive, metastatic medullary thyroid cancer (MTC). The company’s first marketed product will cost $9,900 for a 28-day supply. While MTC is an orphan disease and the patient population for the drug is small, Exelixis hopes that it's the beginning of a more lucrative oncology franchise for Cometriq with data from two phase 3 studies in advanced prostate cancer due in 2014. At ASCO in June 2012, results from the phase EXAM trial in MTC showed that patients on cabozantinib had a median progression-free survival of 11.2 months, compared with 4.0 months for those on a placebo.

November 12,2012 Clovis Oncology CO-101

Clovis Oncology said it would suspend development of its experimental cancer drug, CO-101, on Nov. 12 after the experiment cancer therapy proved to be no better than the standard chemotherapy used to treat pancreatic cancer in the phase 3 LEAP trial. Shares of the company fell 42 percent, the lowest in a year. The average survival for patients on Clovis’ treatment was six months, the same as patients on the standard chemotherapy drug gemcitabine.

November 09,2012 Celgene Abraxane® (paclitaxel)

In highly anticipated top line results from a phase 3 trial, Celgene reported on Nov. 9 that its drug Abraxane had improved survival in patients with pancreatic cancer. The extent of the improvements will not be known until a medical meeting in January however. Abraxane is already approved for use in the treatment of breast and lung cancer. In a Nov. 12 research note, Cowen analyst Eric Schmidt said the chance was high that Abraxane plus gemcitabine could become the new standard of care in pancreatic cancer.

October 27,2012 Teva Pharmaceuticals Synribo™ (omacetaxine mepesuccinate) for Injection

The FDA approved Teva's Synribo to treat adult patients with chronic phase or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs). Synribo received an accelerated approval based on disease response to the drug in studies. But it has yet to demonstrate an improvement in disease symptoms or an increased survival benefit in a clinical trial, the FDA and company said.

October 17,2012 Eli Lilly & Co. Alimta® (pemetrexed for injection)

Lilly said on Oct. 17 that the FDA had expanded its lung cancer drug Alimta’s use as a maintenance therapy following first-line treatment with Alimta plus cisplatin for locally advanced or metastatic nonsquamous non-small cell lung cancer (NS NSCLC). The FDA approved the label inclusion of phase 3 data demonstrating progression-free (PFS) and overall survival (OS) advantages in the continuation maintenance setting for these patients. Appropriate patients can now begin with Alimta plus cisplatin and continue with Alimta in the maintenance setting in advanced or metastatic NS NSCLC. The medication is indicated for the maintenance treatment of patients with locally advanced or metastatic NS NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

October 12,2012 Celgene Corp. Abraxane® (paclitaxel)

On schedule with its PDUFA date of Oct. 12, Celgene won an additional marketing approval from the FDA for its breast cancer drug Abraxane as a first-line treatment for advanced non-small cell lung cancer (NSCLC), in combination with carboplatin, for patients who aren't candidates for curative surgery or radiation therapy. The company announced earlier on Oct. 2 that Abraxane met its primary endpoint of delaying tumor growth in a phase 3 trial as a first-line treatment for metastatic melanoma but withheld details of that study for an upcoming medical meeting. Before the end of 2012 results are also expected from an important phase 3 trial of Abraxane in pancreatic cancer.

September 27,2012 Bayer HealthCare / Onyx Pharmaceuticals Stivarga® (regorafenib) tablets

The FDA approved regorafenib (Bayer and Onyx), which will be marketed as Stivarga, for patients with metastatic colorectal cancer (mCRC) who have been previously treated with currently available therapies. After a priority review, the product was approved one month ahead of its PDUFA goal date of October 27, 2012. Stivarga's approval is based on results from the pivotal phase 3 CORRECT study which showed an improvement in overall survival (OS) and progression-free survival (PFS) compared to placebo in patients with mCRC whose disease had progressed after approved standard therapies. In the trial, patients treated with Stivarga plus Best Supportive Care (BSC) lived a median of 6.4 months versus a median of five months in patients treated with placebo plus BSC; patients treated with Stivarga plus BSC experienced a delay in tumor growth (or PFS) for a median of two months compared to a median of 1.7 months in patients receiving placebo plus BSC.

September 10,2012 Navidea Biopharmaceuticals 99m-Tc-Tilmanocept (Lymphoseek®)

Navidea's stock slumped a day after the FDA issued a Complete Response Letter (CRL) and refused to approve the company's cancer imaging agent on its Sept. 10 action date. U.S. regulators had no concerns about Lymphoseek's safety or effectiveness; the FDA asked that Navidea resolve problems with third-party manufacturers before they approved the product. The company said it would work on a quick turn-around for the NDA resubmission for FDA review. According to one analyst, the targeting agent, which is used by surgeons to identify lymph nodes in patients with breast cancer or melanoma and to indicate whether cancer has spread to a particular lymph node, could now be approved in early November.

September 04,2012 Pfizer Inc. Bosulif® (bosutinib)

The FDA approved Pfizer’s Bosulif for second-line use in patients with previously treated Philadelphia chromosome-positive chronic myelogenous leukemia (CML). The drug is approved for people with the genetic mutation and CML who cannot tolerate other drugs like Novartis’s Gleevec (imatinib), or whose cancer has stopped responding to older treatments. Bosulif was designated an orphan drug by the FDA; less than 200,000 people in the U.S. suffer from CML, which usually affects older adults. According to Pfizer's release, “once daily Bosulif represents the only therapy approved with pivotal trial data that included CML patients treated with imatinib followed by a second generation tyrosine kinase inhibitor (TKI).”

August 31,2012 Medivation / Astellas Pharma Xtandi® (enzalutamide; previously known as MDV3100)

The FDA approves a new drug for late-stage prostate cancer after a three-month priority review, three months ahead of the agency's November 22, 2012 deadline. Men who took Xtandi, administered as a pill, lived a median of 18.4 months, nearly five months longer than the median of 13.6 months for those on a placebo. The life-prolonging benefits of the new drug will come at a high price though--Xtandi will cost $7,450 a month. Like another newly approved prostate cancer pill that extends survival for men, Johnson & Johnson's Zytiga, Xtandi is meant for patients whose prostate cancer has spread or recurred despite treatment and is approved for men who have already tried the chemotherapy drug docetaxel. Medivation plans to make the drug available to patients in mid-September. Xtandi does have side effects, the most serious of which is the risk of seizures for patients.

August 09,2012 Talon Therapeutics Marqibo® (vincristine sulfate liposome injection)

Slightly ahead of its FDA action date of August 12th, the FDA approves Talon's Marqibo on August 9th for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy. The FDA's green light gives the company its first marketed product. Earlier in March an ODAC recommended the approval of Marqibo in a positive vote of 7 to 4 with 2 abstentions.

August 03,2012 Regeneron Pharmaceuticals / Sanofi SA Zaltrap® (aflibercept)

The FDA approved Zaltrap, developed by Sanofi and Regeneron Pharmaceuticals, on August 3, 2012 for use in combination with a chemotherapy regimen called FOLFIRI in patients whose cancer has spread beyond the colon. The approval is also for 2nd line therapy for use in patients previously treated with an oxaliplatin-based regimen. The agency said Zaltrap was approved with a boxed warning stating the drug can cause severe and sometimes fatal bleeding, including gastrointestinal bleeding and the development of holes in the gastrointestinal tract. Zaltrap can also make it more difficult for wounds to heal, the FDA said.

July 21,2012 Onyx Pharmaceuticals Kyprolis™ (carfilzomib)

A week ahead of its targeted FDA decision date Onyx’s carfilzomib gains the FDA's accelerated approval as a treatment for multiple myeloma patients who’ve already received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy. The drug will be marketed as Kyprolis and will be given intravenously to patients.

July 20,2012 Novartis AG Afinitor® (everolimus) tablets

The FDA approved Novartis's Afinitor on June 20th for use in combination with Pfizer's Aromasin to treat certain types of breast cancer. The FDA approved the product to treat postmenopausal women whose breast cancer is HER-2 negative and hormone-receptor positive and didn't respond to treatment with two other therapies, the drugs Femara or Arimidex. In the pivotal phase 3 BOLERO-2 study, treatment with Afinitor plus exemestane more than doubled median progression-free survival (PFS) to 7.8 months, compared to 3.2 months with exemestane alone for women. The drug is the first in a class known as mTOR inhibitors to be approved for post-menopausal women with advanced hormone-receptor positive, HER2-negative breast cancer. Afinitor is already approved for four other types of cancer, including kidney and a rare type of pancreatic cancer. European regulators followed suit and approved the drug for the same breast cancer indication on July 30th.

July 10,2012 Eisai Inc. Halaven® (eribulin mesylate) Injection

Preliminary results from a phase 3 trial (Study 301) of Halaven versus Xeloda® (capecitabine) in women with locally advanced or metastatic breast cancer failed to meet the pre-specified criteria for either of the co-primary endpoints of overall survival (OS) and progression-free survival (PFS), the company reported on July 9. Eisai noted that "the study was a head-to-head comparison designed to show superiority against a commonly used drug approved in an earlier line of therapy than the FDA-approved indication for Halaven." The company said it would discuss the data with health authorities toward a potential regulatory filing.

July 09,2012 Bristol-Myers Squibb Co. and Eli Lilly & Co. / Qiagen Erbitux® (cetuximab) / therascreen® KRAS diagnostic kit

The FDA approved a label extension of Erbitux on July 6 as a first-line treatment in combination with the chemotherapy regimen FOLFIRI making the therapy the first and only FDA-approved drug for treating metastatic colorectal cancer (mCRC) patients with wild-type KRAS. Concurrently, the FDA also approved the first KRAS companion diagnostic test, Qiagen's therascreen KRAS test kit to identify which patients with mCRC should receive Erbitux. The companies said that Erbitux is not indicated for the treatment of KRAS mutation-positive colorectal cancer. The FDA also stated that Erbitux should only be used to treat those mCRC patients who have undergone an FDA-approved test to determine whether the drug will work.

June 22,2012 Roche / Genentech Perjeta™ (pertuzumab)

Roche / Genentech announced that in the phase 3 CLEOPATRA trial women with HER-2 positive metastatic breast cancer who took Perjeta in combination with Herceptin and chemotherapy lived significantly longer without their disease progressing, compared to those treated with Herceptin and chemotherapy alone. Median progression-free survival improved by 6.1 months from 12.4 months for those who received Herceptin and chemotherapy plus placebo to 18.5 months for those who received Perjeta, Herceptin and chemotherapy. The FDA recently approved Perjeta as a new personalized therapy for use with Herceptin and docetaxel chemotherapy to treat people who have not received prior anti-HER2 therapy. The company said it plans to submit the data for presentation at an upcoming medical meeting.

June 21,2012 Onyx Pharmaceuticals carfilzomib (proposed trade name Kyprolis)

Onyx’s stock surged to a lifetime high, gaining 41% in premarket trading, after an FDA advisory panel on June 20 recommended that the FDA approve carfilzomib as a multiple myeloma treatment for patients who'd previously had at least two prior therapies. The final ODAC vote was 11-0 with one abstention. The positive endorsement surprised Wall Street since the FDA had voiced concerns earlier in the week about the drug’s serious side effects including cardiovascular toxicity and lung and liver damage. The FDA will decide whether or not to approve Kyprolis on July 27.

June 21,2012 Sanofi SA semuloparin

An FDA advisory panel rejected Sanofi's semuloparin as a possible treatment to prevent blood clots in chemotherapy patients on June 20. With the 14-1 vote, the panel found that semuloparin didn't provide enough of a benefit to outweigh its risks and supported an FDA staff report saying that the company's data didn’t “provide meaningful support for the approval” for the venous thromboembolism (VTE) treatment among high-risk patients receiving chemotherapy for certain cancers. Sanofi said it expects an FDA decision on the drug in the second half of this year.

June 11,2012 Roche/Genentech Perjeta (pertuzumab)

The FDA approved Perjeta (pertuzumab) on June 8th after a priority review. Perjeta, a new personalized therapy, is used in combination with Herceptin and docetaxel chemotherapy for HER2-positive metastatic breast cancer (mBC) patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. The approval is based on phase 3 data showing that those patients who received the combination of Perjeta, Herceptin and docetaxel lived a median of 6.1 mos. longer without their cancer getting worse (progression-free survival, or PFS) compared to Herceptin plus docetaxel (median PFS 18.5 vs. 12.4 months).

June 06,2012 Merck & Co. / ARIAD Pharmaceuticals Taltorvic® (ridaforolimus)

Merck said the FDA rejected its NDA for ridaforolimus as a maintenance treatment for patients with metastatic soft tissue, or bone sarcoma. The company received a complete response letter from the agency, which said further clinical trials of ridaforolimus would be needed to assess its effectiveness and safety before any potential approval. The FDA decision was in line with an earlier March recommendation from an FDA advisory panel, which advised against approval in a 13 to 1 vote on the basis that the investigational therapy didn't work well enough to offset potentially serious side effects.

May 13,2012 Talon Therapeutics Marqibo® (vincristine sulfate liposomes injection)

Talon announced on Sept. 27, 2011 that the FDA will give an accelerated review to its NDA for Marqibo as a treatment for adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy. The FDA also assigned a PDUFA date of May 13, 2012 to the application. In March, an FDA advisory panel voted to recommend approval of Marqibo. The company said it would commence its proposed phase 3 confirmatory study, HALLMARQ, which will study adults ≥ 60 years old with newly diagnosed ALL, prior to the May PDUFA date.

April 27,2012 Amgen Xgeva® (denosumab)

Amgen received a complete response letter from the FDA rejecting the expanded use of Xgeva in men with prostate cancer that hasn't spread to the bones. According to Amgen's announcement, issued late Tuesday, April 26th, the FDA said it couldn't approve the sBLA in its present form because the effect on bone metastases-free survival didn't outweigh the risks, including osteonecrosis of the jaw, a rare jaw-decay problem. The agency wants to see data "from an adequate and well-controlled trial(s) demonstrating a favorable risk-benefit profile for Xgeva," the drug-maker said. An FDA advisory panel in February rejected Amgen's proposal to expand the bone drug's use, saying it was unclear whether the results were clinically meaningful. Amgen said it would work with the FDA to determine next steps. The action doesn't impact Xgeva's approved indication in the prevention of skeletal-related events in men with bone metastases from prostate cancer.

April 27,2012 GlaxoSmithKline plc Votrient® (pazopanib)

The FDA on April 26th approved Votrient to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy, making it the first drug approved in decades for the rare cancer, which has many subtypes. The approval follows an FDA advisory panel's recommendation for approval by a 11-2 vote in March in which advisors said that the drug's benefits outweighed its risks. In the phase 3 PALETTE trial on which the approval is based, patients being treated with Votrient had a median progression-free survival of 4.6 months compared with 1.6 months on placebo. The oral therapy carries the FDA's toughest boxed warning, alerting patients and health-care professionals about the potential risk of liver damage, which can be fatal. Votrient has been designated an orphan drug for the sarcoma indication, and was also approved in 2009 to treat advanced kidney cancer.

April 11,2012 U-Systems Inc. Automated Breast Ultrasound (ABUS)

The Radiological Devices Panel of the Medical Devices Advisory Committee will meet to discuss, make recommendations, and vote on information related to the premarket approval application for U-System’s Automated Breast Ultrasound (ABUS) scanning device, intended to increase breast cancer detection in asymptomatic dense-breasted women following a negative screening mammogram.

April 06,2012 Spectrum Pharmaceuticals apaziquone

Spectrum announces that its experimental bladder cancer drug failed to meet its primary endpoint in two phase 3 studies. Spectrum said that the drug, apaziquone, flunked a two-year test of tumor recurrence against a placebo. The company offered regulators a revised look at the data. On the heels of that disappointing news, the company said it would buy Allos Therapeutics in a deal valued at $206M, primarily for the synergy the company would offer in advancing Spectrum's hematology franchise development as a leader in lymphoma drugs. Allos has a marketed lymphoma drug, Folotyn, while Spectrum has two oncology products, Zevalin for a form of non-Hodgkin's lymphoma, and Fusilev, which treats the side effects of the chemotherapy drug methotrexate.

April 05,2012 Sanofi / Regeneron Pharmaceuticals Zaltrap® (aflibercept)

Zaltrap fails to meet its primary endpoint in the phase 3 VENICE trial as a first-line treatment in metastatic androgen-independent prostate cancer. The companies said in a statement that "the study did not meet the pre-specified criterion of improvement in overall survival (OS)." Sanofi and Regeneron said they'd conduct a detailed analysis of the VENICE data, with full results to be presented at an upcoming medical meeting. But based on positive results in the phase 3 VELOUR trial of metastatic colorectal cancer reported earlier, the companies simultaneously announce that the FDA has fast-tracked the review of aflibercept for that indication and has assigned a PDUFA date of Aug. 4th for a decision on the BLA.

April 03,2012 Bayer AG / Onyx regorafenib (BAY 73-4506)

Bayer announced that its phase 3 trial, called GRID, evaluating regorafenib in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib achieved its primary endpoint and achieved a statistically significant improvement in progression-free survival (PFS). The company reported a similar successful outcome for regorafenib on Jan. 18th in a trial testing the experimental therapy in colorectal cancer. Bayer said it would present the GRID data at an upcoming medical meeting. The company plans to file for U.S. approval of regorafenib in the metastatic GIST indication.

April 02,2012 Keryx Biopharmaceuticals / Aeterna Zentaris perifosine (KRX-0401)

Keryx's stock lost two-thirds of its value as the company reported that its experimental drug perifosine (KRX-0401) in combination with Xeloda failed to meet a phase 3 study's primary endpoint of improving overall survival versus Xeloda + placebo in patients with refractory advanced colorectal cancer. The negative results cast doubts on whether another late-stage trial of perifosine in multiple myeloma would continue.

March 30,2012 Roche/Genentech and ImmunoGen trastuzumab emtansine (T-DM1)

Genentech reported positive top-line results for its experimental breast cancer drug T-DM1 from the phase 3 study EMILIA that will allow it to seek U.S. and European approval later this year. In the second-line study, the company said that patients with HER-2 positive metastatic breast cancer treated with T-DM1 lived significantly longer without their disease getting worse compared to those treated with GlaxoSmithKline's Tykerb. Detailed data from the study were withheld for presentation at a later medical meeting and will probably be presented during ASCO's Annual Meeting being held from June 1 - 5. Final results for overall survival, a co-primary efficacy endpoint of EMILIA, are not yet mature the company said.

March 27,2012 Affymax peginesatide

The FDA has established an action date of March 27, 2012 under the Prescription Drug User Fee Act (PDUFA) for peginesatide, an erythropoiesis stimulating agent (ESA), proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis. If approved, peginesatide will be the first once-monthly ESA available for that indication in the U.S.

March 21,2012 Talon Therapeutics Marqibo® (vincristine sulfate liposomes injection)

On Mar. 21st, an FDA advisory panel voted 7 yes, 4 no, with 2 abstentions that evidence from clinical studies supported a favorable benefit/risk profile for Marqibo® (proposed trade name) as a treatment for adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) patients in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy. The FDA decision (PDUFA) date for Marqibo is May 13, 2012.

March 20,2012 Merck / ARIAD Pharmaceuticals Taltorvic™ (ridaforolimus) tablets

Merck and Ariad's ridaforolimus failed to win backing by an FDA panel on Mar. 20. The panel voted 13-1 that the drug's risks outweigh benefits. The agency is set to decide on the drug by June 5.

March 20,2012 GlaxoSmithKline Votrient® (pazopanib hydrochloride) tablets

An ODAC on Tuesday morning recommended Votrient for the treatment of advanced soft-tissue sarcoma in a 11-2 vote. The advisory panel found that the drug's ability to improve short-term survival without worsening symptoms in patients who receive chemotherapy outweighed its adverse risks and a lack of evidence that it can extend overall survival. The FDA will now decide whether or not to approve Glaxo's sNDA for the new indication in sarcoma by May 6. If either Votrient or Merck's ridaforolimus, also being reviewed by an ODAC on Mar. 20th, are approved by the FDA, they would be the first targeted treatments for a cancer that invades soft tissue such as muscle, tendons and fat outside the stomach and intestines.

March 07,2012 Eisai /Astex Pharmaceuticals Dacogen® (decitabine) for Injection

The FDA issues a complete response letter to Eisai on March 6th, after an ODAC on Feb. 9th recommended against expanding Dacogen's labelling as a treatment for AML in patients 65 and older who are not considered candidates for induction therapy. The agency said that the primary study (DACO-016) in support of the application did not provide convincing evidence of the safety and effectiveness of DACOGEN for the proposed AML indication.

February 09,2012 Eisai / Astex Dacogen® (decitabine) for injection

An FDA advisory panel recommended against expanding the use of Eisai/Astex's drug Dacogen to treat older patients with acute myelogenous leukemia (AML). The companies are seeking approval from the FDA for Dacogen in AML patients who are age 65 years and older and who aren't considered good candidates for high-dose chemotherapy as an initial treatment for the blood cancer. The panel voted negatively, 10 to 3, with one panelist abstaining, on whether Dacogen "demonstrated a favorable risk/benefit" profile in patients with newly diagnosed AML. The PDUFA date for an FDA decision on the expanded indication is March 6, 2012.

February 08,2012 Amgen Xgeva® (denosumab) injection

An FDA panel voted 12-1 against a new use for Xgeva in prostate cancer, saying the drug's ability to slow the spread of the disease did not translate into meaningful benefits for patients. Amgen is seeking an expansion of the drug’s current indication as a preventive measure for men with recurring prostate cancer that is at high risk of spreading to the bone. The advisory panel, made up primarily of oncologists, said that the drug’s risks, including a 5% risk of osteonecrosis of the jaw, didn’t outweigh the benefit of a four-month potential delay in prostate cancer spreading to the bones. Amgen said it would continue discussions with the FDA during its review of the company's application. A final decision is expected by April 26.

February 01,2012 Medivation / Astellas Pharma MDV3100

Medivation gained 22% after the company said that MDV3100 prolonged the lives of men with prostate cancer prior to a data presentation from the phase 3 AFFIRM trial at the ASCO-GU Congress on February 2nd. Men with prostate cancer that had spread despite chemotherapy lived for 4.8 months longer if they were given MDV3100 rather than a placebo, with few serious side effects. If approved, the drug would compete with Zytiga, approved last April for patients with late-stage prostate cancer who have failed chemotherapy. MDV3100 however does not have to be used in combination with the steroid prednisone.

February 01,2012 Novartis AG Gleevec (imatinib)

The FDA expanded Gleevec's use and granted a regular approval for the drug as a treatment for adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). The approval also highlighted an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.

February 01,2012 Bayer / Algeta Alpharadin (radium-223 chloride)

Full results from the phase 3 ALSYMPCA study of Alpharadin, involving patients with advanced prostate cancer that had spread to the bone, will also be presented this week at the ASCO-GU meeting. Data announced prior to the meeting showed that Alpharadin delayed the time to a first skeletal-related event, including fractures, to 13.6 months for patients, compared with 8.4 months for standard care.

January 31,2012 Roche / Genentech & Curis Erivedge (vismodegib) On Jan. 30th, Roche/Genentech's Erivedge (vismodegib) capsule is approved by U.S. regulators for adults with a type of skin cancer called basal cell carcinoma (BCC), that has spread to other parts of the body or that has come back after surgery or that cannot be treated with surgery or radiation. A capsule taken orally once-a-day, Erivedge is the first FDA-approved medicine for people with advanced forms of the most common skin cancer. The drug's approval, which had been given priority review by the FDA, came well before its March 8th decision date. In a mid-stage study, Erivedge shrank lesions (objective response rate, or ORR) in 43% of patients with locally advanced BCC and in 30% of patients with metastatic BCC, the primary endpoint of the study. The median duration of response was 7.6 months. Vismodegib was developed in collaboration with Curis.

January 31,2012 Cell Therapeutics, Inc. Pixuvri (pixantrone dimaleate) injection

The company announces on Jan. 30th that it has withdrawn its U.S. marketing approval application for Pixuvri because the company required additional time to prepare for the drug's review by an FDA Oncologic Drugs Advisory Committee (ODAC) on Thurs, Feb. 9th. CTI's stock drops 17% in pre-market training. The voluntary withdrawal of the NDA for Pixuvri, whose proposed indication is for patients with relapsed or refractory, aggressive Non-Hodgkin’s lymphoma, means that the FDA will no longer make a decision on the approvability of pixantrone on April 24, 2012. CTI plans to resubmit the Pixuvri NDA in 2012.

January 28,2012 Pfizer Inlyta® (axitinib)

On Jan. 27th, Pfizer wins approval for its twice-a-day pill, axitinib, as a treatment for advanced kidney cancer (renal cell carcinoma) in patients who have failed other therapies. The FDA approved the drug based on a single study of Inlyta in which patients experienced two more months without their cancer worsening than patients taking Nexavar (Bayer/Onyx). Pfizer is also studying Inlyta as a first-line treatment option. The approval came soon after an FDA advisory panel recommended that the drug be approved in a unanimous vote on Dec. 7, 2011.

January 23,2012 Millennium / Takeda Velcade® (bortezomib)

The FDA greenlights a new method of administering Millennium's Velcade by subcutaneous injection, which was previously administered only by intravenous infusion to patients. Velcade is approved for treating both multiple myeloma and mantle cell lymphoma. In clinical trials, the subcutaneous administration of Velcade led to fewer incidence of peripheral neuropathy, a type of nerve damage, in patients than the intravenous version of the drug. The company said that safety and efficacy of the two methods of Velcade administration were otherwise similar.

January 18,2012 Bayer / Onyx regorafenib (BAY 73-4506)

Results from the phase 3 CORRECT study released ahead of the ASCO-GI symposium showed that regorafenib prolonged the lives of patients with metastatic colorectal cancer (mCRC) by about six weeks compared to best supportive care (BSC). After a second interim analysis, patients treated with regorafenib demonstrated a median overall survival of 6.4 months compared to 5 months for patients treated with BSC. Onyx acknowledged that the benefit was modest, but said that the study's results were "clinically meaningful" because patients in the trial were in the last line of therapy with no other treatment options. Regorafenib caused serious side effects to patients in the study including severe and painful sores on the hands and feet (17% of patients), extreme fatigue (10%) and severe diarrhea (7%). Bayer will seek regulatory approval for the once-daily pill later this year. Full data from the study will be presented as a late-breaker on Sat., Jan. 21st at ASCO-GI.

January 18,2012 BTG International Inc. Voraxaze (glucarpidase)

On Jan. 17th, the FDA approved Voraxaze to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys, however patients receiving high doses may develop kidney failure. Voraxaze is administered intravenously.

January 03,2012 AVEO Pharmaceuticals / Astellas Pharma tivozanib

Aveo's stock fell over 17% as top-line results announced on Jan. 3rd from TIVO-1, a pivotal phase 3 trial of its experimental kidney cancer drug tivozanib failed to meet investors' "ultra high expectations," according to one analyst. While tivozanib showed a statistically significant improvement in progression-free survival (PFS) time, with a median of 11.9 mos. in comparison to a median of 9.1 mos for Onyx and Bayer AG's sorafenib (Nexavar®), several analysts said that investors had expected PFS results of 12 to 14 mos. for the experimental therapy. Aveo also said tivozanib showed a statistically significant improvement in PFS in a subpopulation of patients who had no previous cancer treatments--a median of 12.7 mos. that topped 9.1 mos. for sorafenib. The companies will release details of the study at the 2012 ASCO annual meeting in June, and also plan to file for marketing approval for tivozanib as a first-line treatment in advanced RCC in the US and Europe this year.

2011

Date Company Product Event
December 14,2011 Novartis AG INC424 (ruxolitinib)

Data from two pivotal Phase 3 studies of INC424 in patients with myelofibrosis will be presented at ASH. COMFORT-I is evaluating INC424 benefit vs. placebo; COMFORT-II is evaluating INC424 vs. best available therapy. The data will assess measures of spleen reduction, symptom improvement, health-related quality of life and overall survival.

December 14,2011 Novartis Tasigna® (nilotinib)

Novartis will present on Dec. 12 at ASH key data from two phase 3 trials of Tasigna: 36-month follow-up data from the ENESTnd study, comparing Tasigna to Glivec in patients with newly diagnosed chronic phase Ph+ chronic myeloid leukemia (CML), and also results from the ENESTcmr trial assessing the efficacy and safety of switching patients with residual molecular disease on Glivec® (imatinib)(2) treatment to Tasigna.

December 14,2011 Pfizer PF-04449913

On Dec. 12 at ASH, for the first time Pfizer will present data in an oral presentation on PF-04449913, an oral hedgehog inhibitor. The phase 1 study is evaluating the experimental therapy's effectiveness across multiple hematologic cancers, including CML, acute myeloid leukemia (AML), myelodysplatic syndrome, and myelofibrosis.

December 14,2011 Pfizer bosutinib

On Dec. 12, 24-month follow-up data from the phase 3 BELA trial of bosutinib versus imatinib in newly diagnosed chronic phase chronic myeloid leukemia patients will be presented. In addition, an analysis of data evaluating bosutinib as a single-agent in previously treated patients with CML will be presented on Dec. 11.

December 12,2011 Millennium Pharmaceuticals Velcade (bortezomib)

Velcade reduced the risk of death by 31% when used in combination with melphalan and prednisone (VMP) in previously untreated multiple myeloma (MM) patients, according to five-year follow-up data from the phase 3 VISTA trial at ASH. The survival benefit in patients who received Velcade was observed in all patient subgroups, including those older than 75 and those with more advanced stages of the disease. Velcade significantly delayed the time to next treatment--27 mos. vs. 19.2 mos.--and doubled the median treatment free interval compared with those who did not get the Takeda drug--16.6 mos. vs. 8.3 mos. Among patients needing subsequent therapies, OS was significantly longer in those who were initially given Velcade as part of their treatment regimen--55.7 mos. vs 46.4 mos., researchers also said.

December 11,2011 ARIAD Pharmaceuticals ponatinib

In a highlighted study from ARIAD on Dec. 11, early results from a pivotal phase 2 PACE trial of the experimental leukemia drug ponatinib showed it was effective in nearly half of patients who had stopped responding to currently available drugs. Forty-seven percent of chronic myeloid leukemia (CML) patients with chronic-phase disease had a major response to ponatinib, and 39% of patients achieved complete remission of their leukemia. The interim results were from 392 patients who had stopped responding to Novartis' Sprycel and Bristol-Myers Squibb's Tasigna. Ariad plans to file for FDA approval of ponatinib in mid-2012 based on the mid-stage trial results.

December 11,2011 Pfizer Gemtuzumab Ozogamicin (Mylotarg)

Investigator-initiated research on gemtuzumab ozogamicin (Mylotarg) will be presented in the ASH plenary session on Dec. 11. The phase 3 trial tested fractionated doses of gemtuzumab ozogamicin combined to standard chemotherapy in newly diagnosed de novo AML patients aged 50-70. In Oct. 2011, Pfizer voluntarily withdrew its NDA for Mylotarg® (Gemtuzumab Ozogamicin for Injection) for the treatment of relapsed AML. A required post-approval study combining chemotherapy and Mylotarg did not demonstrate improved survival compared with chemotherapy alone in patients aged 18-60 with previously untreated AML.

December 11,2011 Pharmacyclics PCI-32765

In updated results from a small phase 1b/2 study presented at ASH, six-month PFS was greater than 90% in patients with chronic lymphocytic leukemia taking Pharmacyclics' oral, first-in-class Bruton's tyrosine kinase (BTK) inhibitor PCI-32765. The trial included 61 patients with CLL who had stopped responding to at least two other types of treatment. Interim results showed the number of leukemia patients responding to the medicine increased over time. At 10 mos. follow-up, 70% of patients treated with a lower dose of PCI-32756 had a significant improvement in their condition, up from a 48% response rate after six mos. of follow-up. In the high-dose group, 44% of patients responded to PCI-32756 after 6.5 mos. of follow-up. The study's lead author called the data "phenomenal." Just before the ASH data came out, Pharmacyclics' licensed the drug to Johnson & Johnson in a potential $975M deal.

December 10,2011 Roche / Genentech pertuzumab

In a key phase 3 study at SABCS that its lead investigator Dr. José Baselga called "...probably the most positive trial in HER-positive breast cancer," data from the CLEOPATRA trial showed that pertuzumab improved progression-free survival by 6.1 mos when added to Herceptin and chemotherapy (docetaxel) vs. Herceptin and chemotherapy alone. In the late-state trial of 808 patients with previously untreated HER2-positive metastatic breast cancer, women went a median of 18.5 mos. before their tumors worsened or they died, significantly longer than the 12.4 mos. for those who received Herceptin and docetaxel alone. Researchers said it was too early though to determine if the combination of pertuzumab and Herceptin for women could actually save lives. The addition of pertuzumab didn't increase cardiac dysfunction, a troublesome side effect seen with Herceptin.

December 09,2011 GlaxoSmithKline plc Tykerb® (lapatinib)

Results of the phase 3 TEACH study at SABCS showed that the use of Tykerb in the delayed adjuvant setting in women with HER2-positive breast cancer failed to significantly improve disease-free survival (DFS) compared to placebo. An improvement in DFS in Tykerb's favor was seen, but the "result did not meet the prespecified criteria for statistical significance," so the study missed its main endpoint. The TEACH results follow two other disappointing trials of Tykerb in the adjuvant setting (Neo-ALTTO & ALTTO) showing that the drug wasn't as effective as Herceptin. Given the latest results, analysts suggested that the substantial use of Tykerb as an adjuvant breast cancer treatment was "very unlikely."

December 08,2011 Novartis AG Afinitor® (everolimus)

In one of two key phase 3 studies at SABCS that improved progression-free survival (PFS) in women whose breast cancer has spread, results from the BOLERO-2 trial showed that women who took both Afinitor and exemestane (Aromasin), which deprives tumors of estrogen, had a median progression-free survival of 7.4 mos. compared with 3.2 mos. for those on placebo plus exemestane. The clinical trial involved 724 postmenopausal women with hormone receptor-positive metastatic breast cancer. The study's principal investigator, Dr. José Baselga, said the trial ..."was the first time [there was] a strategy to revert endocrine resistance, the holy grail of therapy for endocrine-positive tumors.”

December 08,2011 Roche / Genentech Avastin® (bevacizumab)

A new phase 3 study of Avastin, called AVEREL, at SABCS tested the drug in women with HER2-positive breast cancer, about 20% of all breast cancers. (Avastin's recently revoked FDA approval was for the roughly 80% of breast cancers that are HER2-negative.) Patients in the trial received Herceptin, a cornerstone of HER2-positive breast cancer treatment, and docetaxel, with some women randomized to also receive Avastin. Although there was a three-month improvement in progression-free survival for those patients who received Avastin vs. the control group (16.7 mos. compared to 13.5 mos.), Genentech said the difference wasn't sufficient enough to make the drug likely to gain a regulatory approval for a new indication and they wouldn't try for it.

December 07,2011 Affymax peginesatide

On Dec. 7, an FDA ODAC voted 15 to 1, with 1 abstention, that peginesatide demonstrated a favorable benefit/risk profile for use in the treatment of dialysis patients with anemia due to chronic kidney disease (CKD). If approved early next year, the erythropoiesis stimulating agent (ESA) will compete with similar drugs sold by Amgen and Johnson & Johnson for CKD. Affymax submitted an NDA for peginesatide in May 2011; the scheduled PDUFA date is March 27, 2012.

December 07,2011 Pfizer axitinib tablets (proposed trade name Inlyta)

Pfizer won an ODAC's backing on Dec. 7 for axitinib for advanced kidney cancer in patients who have failed prior treatments. In a unanimous 13-0 vote, the FDA advisory panel decided that the drug's benefits outweigh its risks. Ahead of the meeting, FDA staff had expressed concerns that the number of patients for whom the therapy would be effective was too small. Bloomberg reported that the FDA is expected to decide whether to approve the drug by March 13.

November 20,2011 Spectrum Pharmaceuticals Zevalin® (ibritumomab tiuxetan)

Zevalin for non-Hodgkin's lymphoma (removal of the Bioscan requirement is currently under review by the FDA with a PDUFA action date of November 20).

November 18,2011 Roche / Genentech Avastin® (bevacizumab)

In a painful final decision, FDA Commissioner Margaret Hamburg revoked Avastin’s approval as a treatment for metastatic breast cancer (mBC) in the US, saying there was no evidence that the use of the drug helped women live longer or improved their quality of life and that women taking Avastin were exposed to potentially life-threatening side effects such as high blood pressure and hemorrhaging. Hamburg's decision was in line with a unanimous recommendation to revoke the approval made by an FDA advisory committee last June. A CMS spokesperson said that Medicare would continue to cover the drug's use for breast cancer. Roche said it would start a new phase 3 study of Avastin in combination with paclitaxel in previously untreated mBC and would also evaluate a potential biomarker to help identify people who might derive a more substantial benefit from the drug.

November 18,2011 EUSA Pharma Erwinaze™ (asparaginase Erwinia chrysanthemi)

The FDA approves orphan drug Erwinase for the treatment of acute lymphoblastic leukemia (ALL) as the first and only alternative for patients with hypersensitivity to standard-of-care treatment with E. coli-derived pegaspargase.

November 16,2011 Incyte / Novartis AG Jakafi® (ruxolitinib)

Incyte and partner Novartis win an accelerated FDA approval for ruxolitinib, which will be marketed as Jakafi, the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis. The JAK1 and JAK2 inhibitor was approved slightly ahead of its PDUFA action date of Dec. 3, 2011 and stands to win blockbuster status as a first-in-class treatment for patients with the potentially lethal and rare blood cancer. Jakafi is a pill taken twice daily.

November 08,2011 Bristol-Myers Squibb Co. / Eli Lilly and Co. Erbitux® (cetuximab)

The FDA approves Erbitux for an additional indication in combination with chemotherapy to treat patients with metastatic head and neck cancer.

November 03,2011 Medivation / Astellas Pharma MDV3100

Medivation's stock almost doubled on Nov. 3 in early morning trading as the company and its partner Astellas Pharma announced positive survival data from an interim analysis of a prostate cancer drug trial. The experimental therapy, MDV3100, produced a 4.8-mo. advantage in median overall survival compared to placebo in the phase 3 AFFIRM trial of men with advanced prostate cancer previously treated with chemotherapy. After seeing interim results, the trial's monitoring committee recommended that the trial be halted and MDV3100 be given to all participants.

November 02,2011 MELA Sciences Inc. MELAFind®

The FDA approves Mela Sciences' MelaFind, a first-of-its kind skin-cancer detecting device that could make skin cancer detection and identification far less invasive. The company did not have an easy path to U.S. approval and finally launched a citizen's petition last May to push the agency into making a decision on the device after a 6-month wait. The FDA approved MelaFind for use on clinically atypical pigmented skin lesions with one or more clinical or historical symptoms of melanoma.

October 24,2011 Exelixis Inc. cabozantinib (XL184)

Exelixis shares rose 23% in morning trading as the company reported positive top-line data from its pivotal phase 3 EXAM trial of cabozantinib in patients with advanced medullary thyroid cancer (MTC) on Oct. 24. The drug more than doubled survival time in patients with MTC. Patients who received cabozantinib had median survival of 11.2 months before death or disease progression, compared to 4 months for patients on placebo in the trial. Exelixis said the improvement was greater than it expected.

September 26,2011 Novartis Afinitor® (everolimus)

In new data presented at EMCC from the phase 3 BOLERO 2 trial, combining Novartis’ Afinitor with Pfizer’s Aromasin, an estrogen-blocking drug, to treat post-menopausal women with a certain type of advanced breast cancer more than doubled the time they lived without their disease getting worse. Women on the two drugs had progression-free survival (PFS) of as much as seven months more than women treated with the Pfizer drug alone. The data showed that PFS for women in the Afinitor group was 6.9 months versus 2.8 months for those not taking the Novartis drug -- a 57% improvement. Novartis said it plans to file for regulatory approval by the end of 2011.

September 25,2011 Roche/Genentech and Immunogen trastuzumab emtansine (T-DM1)

Data from a phase 2 study (TDM4450g) comparing the single drug trastuzumab emtansine (T-DM1) to Herceptin plus docetaxel chemotherapy in previously untreated HER2-positive metastatic breast cancer showed that people who received T-DM1 experienced a 41% reduction in the risk of their disease worsening or death (progression-free survival, PFS) and lived a median of five months longer without their disease worsening. It was the first time progression-free survival (PFS) data from a randomised study of T-DM1 was presented. The head-to-head trial was also important because people who received trastuzumab emtansine experienced fewer common and severe adverse events compared to those who received the two-drug standard of care, Herceptin plus chemo, with the rate of Grade 3 or higher adverse events reduced by nearly half.

September 25,2011 Novartis Zometa® (zoledronic acid)

Data from the AZURE trial presented at EMCC showed that Novartis's bone drug Zometa extended survival in older breast cancer patients but failed to improve disease-free survival among younger women patients. In the trial, Zometa only improved overall survival rates in patients who had undergone menopause at least five years earlier. Study results were first presented at SABCS last December.

September 25,2011 Sanofi / Regeneron Pharmaceuticals Zaltrap® (aflibercept)

The addition of aflibercept to standard chemotherapy was associated with about a six-week improvement in overall survival and a two-month increase in progression-free survival compared with chemotherapy alone in results presented at EMCC from the phase 3 VELOUR trial. The study tested aflibercept versus placebo in combination with FOLFIRI in previously treated metastatic colorectal cancer patients. Patients with and without prior exposure to bevacizumab (Avastin) benefited from treatment with aflibercept. Additional findings from a a preplanned subgroup analyses supported the consistency and robustness of the efficacy results across all domains, including prior treatment with bevacizumab.

September 24,2011 Roche / Genentech vismodegib

Full results from the pivotal phase 2 ERIVANCE trial presented at EMCC showed Roche's vismodegib shrank tumors or healed lesions in 43% of people with locally advanced basal cell carcinoma (BCC) and 30% of those with another advanced form of disease. The primary endpoint of the study was overall response rate (tumour shrinkage and healing of visible lesions). Advanced cases of the disease are not always treatable with surgery and there is currently no medical treatment available. Roche announced earlier in September that it had applied for approval to market vismodegib in the U.S. as a skin cancer treatment.

September 24,2011 Roche / Genentech Avastin® (bevacizumab)

Data from a new phase 3 trial called AVAPERL evaluating Avastin in combination with pemetrexed chemotherapy in previously untreated patients with advanced non-small cell lung cancer (NSCLC) showed that the trial met its primary endpoint, giving lung cancer patients significantly more time without their disease progressing. Patients whose disease did not progress continued treatment with Avastin and pemetrexed and lived for a median of 10.2 months without their disease getting worse. AVAPERL is the first phase 3 study to investigate the combination of Avastin and pemetrexed as maintenance therapy and Roche said the study confirmed the importance of maintenance treatment for NSCLC patients.

September 24,2011 Amgen Xgeva® (denosumab)

Data from the ‘147 phase 3 study of Xgeva showed that the bone-targeting drug delayed the onset of bone metastases in men with hormone-resistant prostate cancer, the first large-scale clinical trial to show such an effect.

September 24,2011 Bayer Healthcare Pharmaceuticals / Algeta Alpharadin

Alpharadin, an experimental drug from Bayer and Algeta, prolonged the lives of advanced prostate cancer patients in phase 3 results from the ALSYMPCA trial presented at EMCC. The study’s lead investigator called the results “practice changing.” The study met its primary endpoint and significantly improved overall survival (OS) by 44% in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases. A new drug based on the active ingredient radium 223, Alpharadin delivers minute, highly-charged doses of radiation to secondary tumors in the bone and is designed to treat patients with advanced disease whose cancer has spread to their bones. The trial's main secondary efficacy endpoints analyzed to date were also met, including delay in skeletal-related events (SREs).

September 14,2011 ApoPharma proposed trade name Ferriprox (deferiprone) film-coated tablets

During the morning session of the ODAC Meeting, panelists voted 10-2 to recommend that the FDA grant accelerated approval of Ferriprox® (deferiprone), an oral iron chelator, for the treatment of patients with transfusional iron overload when current chelation therapy is inadequate; during the afternoon session, the FDA advisory panel will consider the development and possible clinical trial design of products for patients with non-metastatic castration resistant prostate cancer (CRPC) who have a rising serum level of prostate-specific antigen (PSA) despite being on androgen deprivation therapy (ADT). There are no drugs currently approved for this indication and no specific drugs will be presented or discussed.

August 29,2011 Pfizer Xalkori® (crizotinib) capsules

Pfizer’s crizotinib, a treatment representing another advance in personalized medicine for cancer patients, was cleared ahead of schedule by the FDA on August 26 for patients with late-stage, non-small cell lung cancer with an anaplastic lymphoma kinase (ALK) gene mutation. Pfizer will sell the twice-a-day pill under the name Xalkori. The agency also approved a companion test made by Abbott to determine whether a patient has the rare genetic abnormality. Follow-up data from a study reported in June showed that 88% of patients saw their tumors shrink at least somewhat after one year on Xalkori. As the drug was given accelerated approval, Pfizer is conducting post-marketing clinical trials to further evaluate its clinical benefit. Xalkori is the first lung-cancer treatment developed and approved with a diagnostic test, Pfizer said. Xalkori is the third cancer drug in August to win FDA clearance ahead of schedule—Roche’s Zelboraf for advanced melanoma and Seattle Genetics’ Adcetris for two types of lymphoma were the others.

August 29,2011 Dendreon Provenge® (sipuleucel-T)

The FDA approved a third immunotherapy manufacturing facility in Atlanta for Provenge on August 26. With the Atlanta greenlight, Dendreon now has three FDA-approved sites for production of its prostate cancer vaccine, including New Jersey and Los Angeles.

August 19,2011 Seattle Genetics / Millennium: The Takeda Oncology Company brentuximab vedotin (proposed trade name Adcetris™)

Adcetris wins accelerated approval from the FDA on Aug. 19 as a treatment for both Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL), ahead of its Aug. 30 PDUFA date. The approval makes Adcetris the first new drug approved for Hodgkin’s lymphoma patients since 1977. Seattle Genetics said on Aug. 22 it will charge $13,500 per dose for the new drug. The product is given as an intravenous infusion every three weeks. The average patient in clinical trials got 7 to 9 doses, the company said on a conference call. The pricing announced is in line with Wall Street expectations which were about $110K per patient. The actual cost could be a lot higher--if a patient gets the maximum number of 16 doses described in the FDA-approved label, it will cost $216K. The drug’s accelerated approval was based on its response rate in patients. The drug significantly shrank tumors in about 75% of patients with Hodgkin’s disease, and in about 86% of patients with ALCL.

August 17,2011 Roche / Genentech / Daiichi Sankyo vemurafenib (proposed trade name Zelboraf)

The FDA granted an early approval on August 17 to Roche's drug Zelboraf for the treatment of advanced melanoma, two months before its actual FDA action date in October. Also known as vemurafenib, the drug targets a mutated gene called BRAF found in roughly half of patients with metastatic melanoma. The FDA also approved a companion diagnostic test to help determine if a melanoma patient has the mutation. Zelboraf is the second new cancer drug approved for melanoma this year that demonstrates an improvement in overall survival (Bristol-Myers Squibb's Yervoy, which Roche's drug will compete with, was approved in March). The company hailed the drug's approval as a major step forward in personalizing the treatment of metastatic melanoma. Roche filed for U.S. approval of the drug in April and the FDA was to make a decision by October 28, but as Reuters first reported last week, the approval was expected earlier. Most patients will take Zelboraf for about 6 months at an estimated cost of $56,400, according to the company.

August 12,2011 ADVENTRX Pharmaceuticals, Inc. Exelbine™(ANX-530)

Prior to a Sept. 1 PDUFA date, Adventrx announces on Aug. 9 that the FDA issued a complete response letter, rejecting a new formulation of their chemotherapy drug Exelbine. The company's shares plunged 61%, to 99 cents after hours, on the news. Regulators said they couldn’t be certain the experimental non-small cell lung cancer treatment is as safe and effective as the original therapy. The agency said Adventrx would have to repeat its Phase 1 bioequivalence trial of the drug because the “authenticity” of drug products used in the original 2007 test couldn’t be verified. The company plans to request a type-A meeting--which is designed to resolve an issue with an otherwise stalled product--next week. Adventrx is seeking approval of Exelbine for the same indications as Navelbine(R), a branded formulation of the generic chemotherapy drug vinorelbine, including NSCLC. The drug initially ran into difficulties with regulators in March 2010 when FDA officials said they needed more information about the therapy before accepting it for review and issued a refuse-to-file letter. After that issue was addressed, regulators accepted an NDA in January and set a Sept. 1 deadline for deciding whether it could be sold in the United States.

July 15,2011 Roche Holding AG / Genentech pertuzumab

Roche/Genentech said that in the phase 3 CLEOPATRA trial, pertuzumab, in combination with Herceptin and chemotherapy, helped some breast cancer patients live "significantly" longer without their disease worsening. Roche said the company would provide more detailed data at an upcoming medical conference later this year; the company also plans to file the drug for approval in Europe and the U.S. later this year. But the lack of detailed data raised concerns that despite Roche's benefit claim, regulators could be skeptical and disapprove of the drug. One analyst said questions such as how big the benefit is and if it showed a trend toward overall survival were important since experience with Avastin showed that success on progression-free survival alone might not convince regulators regarding first-line therapy in metastatic breast cancer.

July 14,2011 Seattle Genetics / Millennium: The Takeda Oncology Company brentuximab vedotin (proposed trade name Adcetris™)

An FDA panel unanimously backed Seattle Genetics’ Adcetris accelerated approval as a treatment for both Hodgkin’s lymphoma and anaplastic large cell lymphoma (ALCL), but recommended stricter labeling. The company is seeking approval for the drug as a first-line treatment option for ALCL and Hodgkin's, not just for previously treated patients. The agency said the company needs more studies confirming safety and efficacy before the drug can get full approval and asked SGEN to develop follow-up studies by August 30, the drug’s PDUFA date, or risk having approval revoked. The company voiced confidence in coming to an agreement with the agency before that date.

July 08,2011 Novartis AG Afinitor® (everolimus) tablets

Novartis said on July 8 that a phase 3 trial of Afinitor had met its primary endpoint of reducing subependymal giant cell astrocytomas (SEGA) tumor size in patients with tuberous sclerosis. More than one-third of patients taking the drug experienced a 50% or greater reduction in the size of their SEGAs, non-cancerous brain tumors associated with tuberous sclerosis complex (TSC). The study, the largest prospective clinical trial to date in this patient population, will be presented on Saturday, July 9 at a medical meeting in Washington, D.C.

July 05,2011 Novartis AG Afinitor® (everolimus)tablets

Novartis announces on July 5 that Afinitor in combination with exemestane significantly extended progression-free survival (PFS) compared to placebo plus exemestane in women with advanced breast cancer in a pivotal phase 3 study of postmenopausal women with ER+HER2- metastatic breast cancer whose disease has progressed, despite initial endocrine therapy. The study, called BOLERO-2, was stopped early after interim results showed the primary endpoint of PFS was met. Full study results are to be submitted for presentation at an upcoming medical meeting and worldwide regulatory filings are planned by the end of 2011 for the indication.

June 30,2011 Dendreon Corp. Provenge® (sipuleucel-T)

The Centers for Medicare & Medicaid Services (CMS) issued a final National Coverage Determination (NCD) on Provenge on June 30, 2011 and said that its program would cover the costly $93,000 price tag for prostate cancer drug Provenge. The CMS coverage decision is in keeping with Provenge's labelling for uses approved by the FDA: for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

June 29,2011 Dendreon Provenge® (sipuleucel-T) (manufacturing expansion)

The FDA gave the green light to Dendreon for a Los Angeles cancer immunotherapy manufacturing facility on June 30, increasing the number of workstations to 84 nationally that will produce its prostate cancer vaccine Provenge. The company already has an approved facility in New Jersey. An FDA approval, with an action date of August 28, 2011, is pending for a third manufacturing facility in Atlanta.

June 28,2011 Roche Holding AG / Genentech Avastin® (bevacizumab)

An FDA ODAC panel unanimously voted to revoke the accelerated approval of Avastin in combination with paclitaxel chemotherapy for previously untreated (first-line) HER2-negative metastatic breast cancer during a hearing on June 29. The panel’s vote is a recommendation only and the drug remains approved for the breast cancer indication until the FDA Commissioner makes a final decision (the agency has not yet announced the timing for that). Roche also announced that EU regulators had expanded the labeling for Avastin in the first-line setting in combination with Xeloda for women with metastatic breast cancer on June 30 just after the U.S. panel’s negative recommendation, giving women another option to the drug's already approved use in combination with paclitaxel as a first-line treatment.

June 17,2011 Celgene Corp. Istodax® (romidepsin) for injection

The FDA granted accelerated approval on June 17 for Celgene's sNDA for an additional indication for Istodax for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy. Istodax is also approved for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. Both indications are based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.

June 06,2011 Exelixis Inc. cabozantinib (XL184)

Exelixis's cabozantinib shrank bone malignancies from prostate cancer in 76% of patients, updated interim results from a phase 2 trial showed on June 6. After 12 weeks of treatment, the drug reduced by 87% the risk of disease progression or death. The company said it would start a phase 3 prostate cancer trial before the end of 2011 with a combined goal of reducing pain and bone malignancies, an unusual trial design for a pivotal prostate cancer study. Other phase 2 data presented on June 4 showed that treatment with cabozantinib led to significant tumor shrinkage in 24% of patients with metastatic ovarian cancer. But Exelixis' shares fell 20% on June 6 after the company reported data over the weekend showing that the experimental cancer drug caused the deaths of six patients in a trial due to side effects. The stock also suffered from new phase 3 trial results reported at ASCO in which a rival drug from Bayer and Algeta helped prostate cancer patients live longer.

June 06,2011 OXiGENE, Inc. Zybrestat™(fosbretabulin tromethamine, or CA4P)

OXiGENE presented final results from the phase 2/3 FACT trial of Zybrestat in combination with chemotherapy (carboplatin and paclitaxel) in patients with ATC at ASCO on June 6. The median overall survival (OS) time was 5.2 months for patients on Zybrestat and chemotherapy compared with 4.0 months for patients receiving chemotherapy alone. One-year survival almost tripled with Zybrestat plus chemotherapy compared to chemotherapy alone (26% vs. 9%). The FACT oral presentation was selected to be included in the Best of ASCO® program following the annual meeting.

June 06,2011 ARIAD / Merck MK-8669 (ridaforolimus)

Detailed results from the pivotal phase 3 SUCCEED trial of oral ridaforolimus in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy were announced on June 6. Earlier in Jan. 2011 ARIAD/Merck announced that the trial had met the primary endpoint of improving PFS compared with placebo--patients were able to keep their tumors in check for a median time of 17.7 weeks on the drug, compared with 14.6 weeks on a placebo. Based on the latest full analysis of PFS, there was a statistically significant 31% reduction by ridaforolimus in the risk of progression or death compared to placebo; also, median PFS was 22.4 weeks for patients on ridaforolimus vs. 14.7 weeks for placebo. The companies said that the data showed that ridaforolimus maintained the benefit of prior conventional chemotherapy. Merck plans to submit marketing applications in both the U.S. and Europe for approval of the drug.

June 06,2011 GlaxoSmithKline Votrient® (pazopanib)

On June 4, GSK announced results from the phase 3 PALETTE study, comparing Votrient vs. placebo in patients with certain soft tissue sarcomas, showing that the drug improved progression-free survival. The study showed a 69% reduction in the risk of progression or death in patients who received pazopanib compared to those who received placebo (the median PFS for patients receiving pazopanib was 4.6 months vs. 1.5 months for those on placebo). Overall survival at the interim analysis was not statistically significant.

June 06,2011 Neoprobe Lymphoseek® (tilmanocept)

Full results from NEO3-09, a phase 3 study of receptor-targeted tilmanocept vs. vital blue dye in the evaluation of sentinel lymph nodes (SLNs) in breast cancer and melanoma, was presented at ASCO on June 6. The data reaffirmed earlier top-line results that showed Lymphoseek met all primary and secondary endpoints and exhibited superior performance to vital blue dye in intraoperative lymphatic mapping (ILM) procedures. Vital blue dye is currently the only FDA-approved, on-label agent for (ILM) procedures. NEO3-09 is intended to be the final Phase 3 study for initial U.S. registration of the lymphatic tissue tracing agent.

June 06,2011 Novartis / Incyte ruxolitinib (INC424)

Data from two pivotal phase 3 studies evaluating ruxolitinib in patients with myelofibrosis, for which there are no currently approved treatment options, showed that the investigational agent had an impact on the disease and improves quality of life for patients. Both studies COMFORT-II and COMFORT-I met their primary efficacy endpoint. COMFORT-II study demonstrated that ruxolitinib produced a spleen size reduction of 35% or greater in 28.5% of myelofibrosis patients compared to 0% of patients in the best available therapy (BAT) arm at 48 weeks. Ruxolitinib could become the first approved treatment option for the disease.

June 06,2011 Cyclacel Inc. sapacitabine

New interim data at ASCO from a phase 1/2 clinical trial of oral sapacitabine, administered sequentially with Eisai’s Dacogen (decitabine), was important since it indicated what Cyclacel’s drug might achieve in an elderly population with AML. The treatment regimen under evaluation in this pilot study is being used as one of the arms in SEAMLESS, the registration-directed, phase 3 study of sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia who are not candidates for intensive induction therapy. Thirty-day mortality from all causes was 4.5%. Sixty-day mortality from all causes was 9.5%. The overall response rate was 34.8%. The study data highlighted the safety and efficacy of sequential administration of sapacitabine and decitabine in elderly patients with AML.

June 05,2011 Bristol-Myers Squibb Yervoy™ (ipilimumab)

In phase 3 study results announced on June 5, Yervoy met its primary endpoint in a first-line study and prolonged the lives of patients with metastatic melanoma when combined with chemotherapy compared to chemotherapy alone. In study 024 evaluating newly-diagnosed patients treated with Yervoy in combination with dacarbazine vs. dacarbazine alone, there was a significant improvement in overall survival for patients in the Yervoy plus dacarbazine arm vs. those in the dacarbazine arm alone (estimated rates were 47.3% vs. 36.3% at one year, 28.5% vs. 17.9 % at two years and 20.8% vs. 12.2 % at three years).

June 05,2011 Roche / Genentech / Daiichi Sankyo vemurafenib (RG7204 / PLX4032)

In phase 3 (BRIM3) trial results called "better than expected," after a median three months of treatment patients receiving vemurafenib had a 63% reduction in the risk of death compared to patients given the chemotherapy drug dacarbazine. The study included patients with previously untreated, inoperable, advanced metastatic melanoma with a BRAF mutation. Vemurafenib patients also had a 74% reduction in the risk of cancer progression compared to dacarbazine, and nearly 50% treated with the Roche drug had tumor shrinkage, compared to only 5.5% in the chemotherapy group. Positive results from both BRIM3 and BRIM2, also presented at ASCO, are the basis of Roche's new drug applications for vemurafenib in the U.S. and Europe, announced on May 10.

June 05,2011 Astellas Pharma / Roche Tarceva® (erlotinib)

In advance of an oral presentation over the weekend, Genentech announced updated interim results in a June 2 press release and said that the EURTAC phase 3 study showed that first-line Tarceva nearly doubled median PFS for people with NSCLC with EGFR activating mutations compared with chemotherapy (9.7 months compared to 5.2 months) and reduced the risk of lung cancer getting worse by 63%. The trial is the first phase 3 study of Tarceva compared with chemotherapy in a Western population of people who had not previously been treated for the genetically distinct form of advanced lung cancer.

June 05,2011 Novartis Gleevec® (imatinib)

Novartis announced new data on June 5 from the phase 3 (SSGXVIII/AIO) trial showing a significant improvement in both recurrence-free survival and overall survival for patients taking Glivec for three years after surgery to remove KIT+ gastrointestinal stromal tumors (GIST) compared to one year of treatment. Data show 66% recurrence-free survival and 92% overall survival at five years following three years of adjuvant therapy with Gleevec in patients with resected KIT+ GIST. The findings could result in the three-year course of therapy becoming the new standard of care for those patients who are at risk for relapse.

June 05,2011 Roche MetMAb

Final efficacy results presented from a phase 2 study (OAM4558g) evaluating MetMAb, an investigational personalised medicine, or placebo in combination with Tarceva in advanced NSCLC, were presented on June 5 at ASCO. Roche released study results earlier, on May 19, showing that people whose tumours had high levels of Met, as determined by a companion diagnostic, lived twice as long without their disease getting worse when they received MetMAb plus Tarceva compared to Tarceva alone.

June 04,2011 Roche / Genentech Avastin® (bevacizumab)

Data from the second-line phase 3 OCEANS study showed that Avastin in combination with chemotherapy in women with recurrent ovarian cancer reduced the risk of disease progression by 52% compared to treatment with chemotherapy alone. And in an early analysis of overall survival of the OCEANS study, women receiving Avastin plus chemotherapy lived 35.5 months compared to 29.9 months in women who received chemotherapy alone--a trend favoring Avastin but not yet statistically significant. In a second phase 3 study, ICON7, for women with newly diagnosed ovarian cancer, Roche/Genentech reported for the first time that treatment with Avastin resulted in a 15% reduction in the risk of death.

May 23,2011 Genta Inc. Genasense® (oblimersen sodium) Injection

Prior to ASCO, the company announces on May 23 that overall survival for patients treated with Genasense plus chemotherapy in AGENDA, a phase 3 trial of Genasense® in patients with advanced melanoma, was not significantly superior compared with patients treated with chemotherapy alone. In the trial, median survival was 13.5 months in the Genasense group and 13.1 months in the chemotherapy-only group.

May 06,2011 Novartis Pharmaceuticals Corp. Afinitor® (everolimus) tablets

Not long after an ODAC panel recommended its approval on April 12, Novartis’ Afinitor is approved by the FDA for pancreatic neuroendocrine tumors (NET) on May 5. The company said it was the first approval of a treatment for the condition in the U.S. in nearly 30 years. The approval was based on data from a drug trial that showed Afinitor more than doubled the time patients went without tumor growth. The FDA determined that the safety and effectiveness of the drug in treatment of patients with carcinoid tumors was not established, however.

April 30,2011 Spectrum Pharmaceuticals Fusilev® (levoleucovorin) for Injection

On April 29, Spectrum received FDA approval for Fusilev, a branded version of levoleucovorin, for use as a palliative treatment for patients with advanced metastatic colorectal cancer. Earlier on April 21, U.S. regulators approved a ready-to-use injection form of Fusilev, a treatment that is a higher strength than the currently available formula. The drug was originally approved in 2008 for use with osteosarcoma patients to reduce the toxic impact of a specific type of chemotherapy.

April 29,2011 Johnson & Johnson / Centocor Ortho Biotech ZYTIGA™ (abiraterone acetate)

After a priority review, the FDA approves abiraterone, an oral, once-daily medication for use with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel. The agency's approval for the drug came almost two months ahead of its June 20, 2011 regulatory goal date.

April 12,2011 Novartis Pharmaceuticals Corp. and Pfizer Inc. Afinitor (everolimus) tablets and Sutent (sunitinib malate) capsules

An ODAC panel found that the benefits of Novartis' Afinitor and Pfizer's Sutent as potential treatments for pancreatic neuroendocrine tumors (NET) outweighed their risks and voted to recommend the approval of both drugs. The panel endorsed Afinitor in a 10-0 vote but the committee was less certain about Sutent, voting 8-2 in favor of approval. Some panelists had concerns over possible side effects including heart and kidney failure. Novartis expects the FDA to make a decision on Afinitor by the end of June; Pfizer said FDA action on Sutent was expected by the end of 2011.

April 07,2011 AstraZeneca PLC vandetanib

A day ahead of the FDA's anticipated action date of April 7 for vandetanib, U.S. regulators approve AstraZeneca's oral drug for adult patients with (metastatic) medullary thyroid cancer (or MTC)--making it the first FDA-approved treatment for the rare type of thyroid cancer.

March 30,2011 Dendreon Corp. Provenge® (sipuleucel-T)

The Centers for Medicare & Medicaid Services (CMS) said on March 30 in a proposed decision memo that Provenge should be covered by Medicare since the $93,000 drug regimen is “reasonable and necessary” for older men with advanced, castrate-resistant prostate tumors who are asymptomatic or minimally symptomatic. The CMS will issue a final National Coverage Determination (NCD) on the cancer vaccine by June 30, 2011. A panel of outside advisers to Medicare said last November that they were confident that Provenge significantly improved survival in men with advanced tumors. The CMS' proposed decision is in keeping with Provenge's approved labelling.

March 26,2011 Bristol-Myers Squibb Co. Yervoy™ (ipilimumab)

The FDA approves Bristol’s ipilimumab for patients with newly diagnosed or previously-treated metastatic melanoma on Mar. 25. Ipilimumab is the first and only FDA-approved metastatic melanoma therapy to have shown a significant improvement in overall survival for patients with the disease, and the first therapy for advanced melanoma to be approved in more than a decade. U.S. regulators approved the drug as a first-line treatment for patients in addition to approving it for patients already treated, a wider population than originally expected. The company said the drug would begin shipping within a few weeks; a standard regimen will cost $120,000.

March 22,2011 Bristol-Myers Squibb Co. Yervoy™ (ipilimumab)

Close to its anticipated FDA action date on Mar. 26 as a second-line treatment for metastatic melanoma, Bristol reports that ipilimumab meets its primary endpoint of improving overall survival in a front-line study (dubbed study 024). The study randomized patients to treatment with the combination of ipilimumab plus the chemotherapy drug DTIC, or DTIC alone. Patients had advanced melanoma and had not been previously treated with other drugs. Bristol doesn't release any data on the phase 3 study but says it will submit the abstract for presentation at ASCO in June. Ipilimumab is later approved on Mar. 25 as both a first- and second-line treatment for patients with metastatic melanoma.

February 22,2011 Delcath Systems Percutaneous Hepatic Perfusion (PHP) for cancer-related liver metastases

Delcath shares fell 38% after the company disclosed the FDA issued a refuse-to-file letter for the company’s “chemosaturation system” which floods the liver with high doses of the chemotherapy drug melphalan. Delcath is seeking approval for the system as a treatment for skin cancer patients who have tumors that spread to the liver. FDA requested additional safety data related to melphalan and the Delcath system, which the company intends to collect and submit to the agency no later than September. A September resubmission could lead to a March 2012 FDA approval decision.

February 09,2011 Imclone Systems, GlaxoSmithKline, Genzyme Corp., Amgen Inc. and Novartis Pharmaceuticals Corp. Erbitux (cetuximab); Bexxar (tositumomab and Iodine I 131 tositumomab); Arranon (nelarabine) Injection; Clolar (clofarabine) for intravenous infusion; Vectibix (panitumumab); and Gleevec (imatinib mesylate) tablets

An ODAC meeting is scheduled during which the committee will receive updates on the products indicated, granted accelerated approvals before Jan. 1, 2009, for the purpose of a general discussion on ways to improve the planning and conduct of Phase 4 trials to confirm clinical benefit (postmarketing requirements).

February 01,2011 Antisoma plc AS1413 (amonafide)

British biotech Antisoma fell by 65% as another one of its key drugs failed—the phase 3 ACCEDE trial of AS1413 (amonafide) in secondary AML did not meet its primary endpoint; the company said it would discontinue development of the experimental drug, which had received fast-track status from the FDA for the indication. Antisoma had hoped the drug would be effective in treating patients that had a high level of resistance to other drugs. In March ’10, Antisoma's lead lung cancer drug failed. It also announced in its Jan. 31 statement that it had terminated a trial on another drug, AS1411, for blood cancers and solid tumours. The company said it would “become smaller and focus on maximising the value of other programmes."

January 29,2011 Roche / Genentech & Biogen Idec Rituxan® (rituximab)

The FDA approves Rituxan as a maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with Rituxan plus chemotherapy (induction treatment). The approval is based on the phase 3 PRIMA study, which showed that the continued use of Rituxan every two months for two years in those patients nearly doubled the likelihood of them living without the disease worsening (progression-free survival or PFS) compared to those who stopped treatment.

January 27,2011 sanofi-aventis / BiPar Sciences iniparib (BSI-201)

Sanofi-aventis’s stock fell the most in 6 months after one of its most promising pipeline drugs, iniparib, failed to improve survival or slow disease progression in women with metastatic triple negative breast cancer (mTNBC) in a late-stage clinical trial.

January 19,2011 ARIAD / Merck ridaforolimus

Ariad shares jumped 32% in premarket trading as ridaforolimus, being tested in the phase 3 SUCCEED study for treating metastatic soft-tissue and bone sarcomas, met its primary endpoint and improved progression-free survival compared to a placebo. Patients treated with the oral investigational therapy reported a 28% reduction in risk of cancer progression compared to patients treated with a placebo, a highly statistically significant result. The trial targeted patients who had a favorable response to chemotherapy. Ariad's partner, Merck, plans to file for approval later this year based on positive data from Tuesday's study.

2010

Date Company Product Event
December 30,2010 Bristol-Myers Squibb Co. Yervoy™ (ipilimumab)

On Dec. 30, 2010, the FDA posts a brief notice on their website saying that the Feb. 9, 2011 ODAC meeting has been cancelled “because the issues for which the FDA was seeking the scientific input of the committee have been resolved.” The advisory panel was to discuss the BLA for ipilimumab (proposed trade name Yervoy) submitted by Bristol-Myers Squibb Co., whose proposed indication is for the treatment of advanced melanoma in patients who have received prior therapy. The FDA is scheduled to make an approval decision on ipilimumab on March 26, 2011.

December 27,2010 Merck & Co. Gardasil® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

Merck announced in mid-June that the FDA had extended its review of the company's application to broaden use of its cervical-cancer vaccine to include older women. The company began seeking regulatory approval more than two years ago to expand Gardasil's use in women up to age 45, but US regulators said they wanted to see longer-term efficacy data, after four years of follow-up. Merck submitted that data in late 2009, but hasn't yet publicly disclosed the results. Merck expects a response from the FDA by the end of the year.

December 23,2010 sanofi-aventis / Regeneron Pharmaceuticals aflibercept

An interim analysis from the pivotal Phase 3 VELOUR trial of aflibercept plus FOLFIRI in 2nd line colorectal cancer is expected in 2H10, with full results expected in 2H11. VELOUR may provide the first randomized evidence of the effect of VEGF blockade post-bevacizumab. The primary endpoint of the trial is overall survival.

December 23,2010 Bristol-Myers Squibb ipilimumab

Results are due from a Phase 3 study of the drug in first-line, or newly treated melanoma patients comparing ipilimumab plus the chemotherapy DTIC against DTIC plus a placebo. Overall survival is the study's primary endpoint. The company presented positive results at ASCO from a Phase 3 study of the drug in previously treated melanoma patients and said it would seek FDA approval based on the data despite questions about the strength of the results.

December 23,2010 Cyclacel Pharmaceuticals seliciclib

Results from a Phase 2 study in patients with non-small cell lung cancer are due by year's end.

December 23,2010 BioCryst Pharmaceuticals forodesine

Final results from a phase 2 study of forodesine in chronic lymphocytic leukemia (CLL) are expected later in 2010 at an upcoming medical meeting.

December 22,2010 EpiCept Corp. Ceplene® (histamine dihydrochloride)

EpiCept is seeking FDA approval for Ceplene, administered concomitantly with low-dose interleukin-2 (IL-2), for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first complete remission. Phase 3 data showed that patients with AML in complete remission who received up to 18 months of treatment with Ceplene/IL-2 experienced a significantly longer period of leukemia-free survival (LFS) compared to the standard-of-care, which is no treatment. The company submitted an NDA on June 29 and requested priority review. If granted, priority review should result in an FDA decision date in late December 2010.

December 19,2010 Celgene Corp. Abraxane® for injectable suspension (paclitaxel); Amrubicin

The company could have data from two important, phase 3 clinical trials before the end of 2010: A phase 3 study of Abraxane in front-line non-small cell lung cancer and a phase 3 study of Amrubicin in small-cell lung cancer (the latter study may not be completed until early 2011 however.)

December 18,2010 Roche / Genentech Avastin® (bevacizumab)

In a blow to Roche/Genentech, the FDA announces on Dec. 16 its recommendation to remove the breast cancer indication from Avastin’s labelling after reviewing data from four independent studies. The FDA says that the data indicates that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh its significant risk to patients. Roche/Genentech has 15 days to respond to the FDA’s notification & request a public hearing.

December 14,2010 Amgen Xgeva™ (denosumab)

Amgen’s stock rose 8% premarket on Dec. 14 after the prior day's close as top-line results from its pivotal phase 3 ‘147 study showed that Xgeva delayed the spread of prostate cancer to the bones by 4.2 months. The drug was approved for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors on Nov. 18, and, at a lower dose and as Prolia, to prevent osteoporosis. Analysts said that the positive key late-stage data and potential new use could make Xgeva a blockbuster drug.

December 12,2010 Onconova Therapeutics Estybon™ (also known by code name ON 01910.Na)

Ongoing studies of Estybon have enrolled a broad range of patients with myelodysplastic syndromes (MDS) with various cytogenetic markers and classifications. Results from these MDS trials, including survival data, will be presented at the ASH annual meeting in December 2010 in Orlando, FL. A pivotal phase 3 trial testing Estybon as a monotherapy in MDS patients and comparing its efficacy and safety to Best Supportive Care (BSC) began enrollment in 4Q '10.

December 07,2010 Onyx Pharmaceuticals carfilzomib

Full results of the phase 2b PX-171-003-A1 study of carfilzomib in patients with relapsed and refractory multiple myeloma will be presented at ASH on Tuesday, Dec. 7, 2010, at 7:30 am EST. Onyx plans to submit an NDA filing for accelerated approval as early as mid-2011 based on the data.

December 07,2010 Seattle Genetics / Millennium: The Takeda Oncology Company brentuximab vedotin (SGN-35)

Full results of a phase 2 trial in relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) will be presented in an oral presentation at ASH on Tuesday, Dec. 7, 2010 at 7:30 am EST. Based on overall response rates of 86% in ALCL and 75% in HL with single-agent brentuximab vedotin reported in October and September, respectively, the company said in a statement that it would discuss regulatory next steps with the FDA later this year with the goal of including both indications in their BLA submission, planned for the first half of 2011.

December 06,2010 Novartis LBH589 (panobinostat)

Pivotal phase 2 data for LBH589 in the treatment of Hodgkin lymphoma patients who relapse or are refractory after autologous stem cell transplant will be presented on Monday, Dec. 6 at 11:30 AM EST.

December 06,2010 Pfizer bosutinib

Key highlighted data from Pfizer at ASH includes results from the ongoing, phase 3 BELA study of bosutinib versus imatinib in newly diagnosed patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) to be released as an oral presentation on Monday, Dec. 6.

December 06,2010 Seattle Genetics / Millennium: The Takeda Oncology Company brentuximab vedotin (SGN-35)

Full results from the pivotal phase 2 trial of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma (HL) will be presented in an oral session at ASH in Orlando, Fla., on Monday, Dec. 6, 2010, at 7:00 am EST. Positive top-line data from the trial was reported in September (see our Dec. 7 Radar entry on brentuximab vedotin for more details).

December 06,2010 Novartis Zometa® (zoledronic acid)

Phase 3 data evaluating Zometa in the treatment of patients with newly diagnosed multiple myeloma will be presented on Monday, Dec. 6 at 8:00 am EST.

December 06,2010 Novartis Tasigna® (nilotinib); Glivec® (imatinib)

A 24-month update from the Phase 3 ENESTnd study, comparing Tasigna to Glivec in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase, will be presented on Monday, Dec. 6 at 7:30 am EST. ENESTnd is an ongoing trial and 18-month data were presented at ASCO in June 2010. These data showed that Tasigna produced deeper levels of molecular response than Gleevec in front-line Ph+ CML, fewer progressions to accelerated phase and blast crisis and fewer deaths. The trial is the longest-term comparative study of a second-generation tyrosine kinase inhibitor to date.

December 05,2010 Amgen Nplate® (romiplostim)

Key data from Amgen at ASH will include a phase 3 study on Nplate’s long-term safety and efficacy in chronic immune thrombocytopenic purpura (ITP), which will be presented on Sunday, Dec. 5.

December 05,2010 Novartis Afinitor® (everolimus)

Two studies showing the activity of everolimus in mantle cell lymphoma will be presented on Sunday, Dec. 5 between 6:00-8:00 pm EST and Monday, Dec. 6 between 6:00-8:00 pm EST, respectively.

December 03,2010 AstraZeneca PLC proposed trade name Zictifa™ (vandetanib) Tablets

An FDA advisory panel backed the use of AstraZeneca's drug vandetanib to treat medullary thyroid cancer, but said the drug should be reserved for patients who are experiencing symptoms of their disease. The panel didn’t directly vote on whether to recommend that the FDA approve the drug but were asked to vote about whether additional doses of the drug should be studied "if there is a patient population in which the risk-benefit profile is acceptable." The ODAC panel voted 10 to 0 in favor of requiring study of additional doses in post-market studies, or after the drug is approved. The FDA had expressed concerns over the "substantial toxicity" associated with the drug's proposed dose. Most panel members said the drug should be used only in patients whose disease is progressing and are experiencing pain and other symptoms, like difficulty swallowing.

December 01,2010 GlaxoSmithKline plc / Merck & Co. Avodart® (dutasteride)/ Proscar® (finasteride) tablets

An FDA advisory panel said that drugs currently used to treat enlarged prostates in men shouldn't be used as a treatment to prevent prostate cancer due to concerns that the drugs did not cut the risk of aggressive prostate tumors. The panel voted 14-2 against backing GSK's application for formal approval to expand the use of Avodart in men at risk for prostate cancer. The panel also voted 17-0 with one abstention that Merck's Proscar has an unfavorable balance of risks and benefits in healthy men at least 55 years old, turning down Merck's request to add data from its studies in prostate cancer to the prescribing information for Proscar, which was approved in 1992.

November 18,2010 Amgen Xgeva™ (denosumab)

The FDA approves Xgeva, the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Amgen's BLA received a priority review and approval on the basis of three pivotal Phase 3 head-to-head trials testing denosumab versus Novartis' Zometa. In the three trials Xgeva demonstrated a clinically meaningful improvement in preventing SREs compared to Zometa.

November 18,2010 MELA Sciences Inc. MELAFind®

In spite of doubts that it would win a green light from an FDA advisory panel, panelists voted favorably for MELA Sciences' skin cancer-detection device, MELAFind, on Nov. 18. The panel voted 10 to 6 in favor of the device being safe; the panel also voted by a small margin in both instances that the device was effective and that its benefits outweighed the risks. Wall Street continued to speculate, however, that the company would not have an easy path to gaining FDA approval for MELAFind, which was rejected for approval in March 2010. Prior to the advisory committee meeting, MELA's shares plunged over 50% as briefing documents were released. The FDA has not said when it will issue another approval decision for MELAFind.

November 17,2010 Merck & Co. Gardasil® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

An FDA advisory committee said that Gardasil appeared effective for preventing anal cancer in both men and women. The advisers didn’t vote but most said that Gardasil was shown effective in company studies. The FDA will weigh the panel's advice as it decides whether to approve Gardasil as a vaccination for males and females ages 9 through 26 for preventing anal cancer.

November 17,2010 Dendreon Corp. Provenge® (sipuleucel-T)

Dendreon Corp. won the backing of an outside advisory panel helping Medicare decide whether to pay for its $93,000 prostate cancer treatment. The panel voted 3.6 on a 5-point scale, showing confidence in the drugs survival benefit for men with advanced prostate cancer. According to the Centers for Medicare & Medicaid Services (CMS), a draft guidance memo will be issued by March 30, 2011, and the expected National Coverage Analysis (NCA) completion date is June 30, 2011.

November 15,2010 Eisai Inc. Halaven™ (eribulin mesylate) Injection

The FDA approves eribulin mesylate for women with advanced breast cancer after at least two prior chemotherapy regimens, more than six weeks earlier than the expected deadline of Dec. 30 for the review. Halaven prolonged survival by 2.5 months compared with current single-agent therapies in the phase 3 EMBRACE study of 762 women with advanced stages of the disease. The drug will compete with Roche’s Xeloda and Bristol-Myers Squibb Co.’s Ixempra. Eisai will start selling its new breast-cancer treatment on Nov. 26.

October 28,2010 Bristol-Myers Squibb / Otsuka Pharmaceutical Co. Ltd. Sprycel® (dasatinib)

Right on schedule, the FDA approves Bristol-Myers Squibb's Sprycel on Oct. 28 as a first-line treatment for patients with Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML). The decision was based on the results of the pivotal phase 3 DASISION trial, which found that the BMS drug was more effective than Novartis AG’s Gleevec, long the leading drug in treating CML. Sprycel was first approved in 2006 to treat adults who were intolerant or resistant to other therapies for CML.

October 28,2010 Exact Sciences Corp. stool-based DNA (sDNA) screening test

In preliminary results that the study's lead investigator said were "remarkable," Exact Sciences' genetic screening test for colon cancer was able to detect 85% of colon cancers and 64% of early, pre-cancers. The data, the first to measure the colon cancer test's sensitivity, was announced at an AACR conference on colorectal cancer on October 28. The results could put the company's test ahead of currently used fecal blood tests in detecting the early warning signs of colon cancer.

October 20,2010 Roche Holding AG / Genentech Herceptin® (trastuzumab)

The FDA approves the use of Herceptin with chemotherapy for advanced HER2-positive advanced stomach cancer. The approval was based on results from the pivotal phase 3 ToGA study showing that the drug combination extended survival in patients compared with chemotherapy alone. Herceptin is already approved for breast cancer patients whose tumors generate the HER-2 protein.

October 11,2010 Novartis AG Afinitor® (everolimus)

In the RADIANT-3 study, Afinitor tablets in combination with octreotide LAR extended progression-free survival in patients with advanced neuroendocrine tumors compared with those taking octreotide LAR alone. While the study failed to meet its primary endpoint, Novartis said Afinitor plus octreotide LAR provided a clinically meaningful extension in the median time without tumor growth to 16.4 months from 11.3 months, when compared with placebo plus octreotide LAR. The company said the data from RADIANT-2 and RADIANT-3 would form the basis for an sNDA for Afinitor later in 2010.

October 11,2010 Seattle Genetics / Millennium brentuximab vedotin (SGN-35)

Eighty-six percent of patients with anaplastic large cell lymphoma (ALCL) responded to brentuximab vedotin based on top-line data reported from a phase 2 trial, Seattle Genetics said on Monday. All of the patients in the trial no longer responded to currently available therapies. Positive results were reported on Sept. 27 from a phase 3 trial of brentuximab in advanced Hodgkin's lymphoma. Full results from both trials will be presented in December at ASH.

October 11,2010 Allos Therapeutics Folotyn® (pralatrexate injection)

Allos’s Folotyn increased non-small cell lung (NSCLC) cancer patients' survival rate more than an existing treatment in a phase 2b study of previously treated patients with advanced NSCLC. After six months, 56% of patients treated with Folotyn were alive, versus 51% with Tarceva (erlotinib). Tarceva, however, demonstrated a higher median survival rate at 7 months, compared with Folotyn's 6.7 months.

October 11,2010 Johnson & Johnson / Cougar Biotechnology abiraterone acetate

Advanced prostate cancer patients who no longer responded to chemotherapy survived about four months longer after treatment with abiraterone compared to similar patients treated with a placebo, based on phase 3 study data presented at ESMO. The study used abiraterone in patients with prostate cancer that no longer responded to hormone therapy and chemotherapy--so-called third-line patients.

October 11,2010 OXiGENE Inc. Zybrestat™ (fosbretabulin, CA4P)

Additional data from the phase 2/3 FACT study strengthened previous findings reported in mid-Sept showing that Zybrestat, in combination with chemotherapy, improved the overall survival (OS) of patients and suggested meaningful survival benefit in multiple subgroups of patients, including patients who were heavily pretreated with surgery, radiation or chemotherapy as well as patients less than 60 years of age. Additional phase 2 lung cancer data will be reported at the EORTC/AACR/NCI meeting in November.

October 11,2010 Seattle Genetics SGN-75

The company announced preliminary results from a phase 1 dose escalation study of SGN-75 in non-Hodgkin lymphoma or renal cell carcinoma (RCC)—the preliminary results showed that one NHL patient experienced complete remission and one RCC patient had a partial response. Seven patients in total had stable disease. The maximum tolerated dose had not yet been reached in the trial.

October 11,2010 ArQule Inc. / Daiichi Sankyo ARQ 197

In additional data analyses reported from a phase 2 trial (Study 209) in non-small cell lung cancer (NSCLC) at ESMO, patients treated with ARQ 197 plus erlotinib had a median time to develop new metastases of 7.3 months, compared to 3.6 months for patients treated with erlotinib plus placebo. Additional presentations scheduled for Oct. 11 will include data from other trials evaluating ARQ 197 in combination with sorafenib and gemcitabine, respectively.

October 11,2010 Roche Holding AG / ImmunoGen trastuzumab-DM1 (T-DM1)

Early interim results from a phase 2 study of T-DM1 reported at ESMO showed that the armed antibody delivered a higher response rate with fewer side effects than the standard treatment of Herceptin plus chemotherapy. After six months, women on T-DM1 had an overall response rate of 48%, compared with 41% for patients in the Herceptin plus Taxotere (docetaxel) arm. ESMO officials announced key findings on Oct. 8 in advance of the Oct. 11 presentation because the study’s embargo had been broken.

October 10,2010 Amgen denosumab

Amgen said that an integrated analysis of three, large phase 3 trials demonstrated that denosumab was superior to Zometa in delaying or preventing time to first-and-subsequent Skeletal Related Event (SRE) in a broad population of cancer patients with bone metastases. Denosumab was superior to Zometa in delaying time to first on-study SRE by 17% percent and was also superior to Zometa in delaying time to first-and-subsequent on-study SRE by 18%. Overall disease progression and survival were similar for both groups.

October 09,2010 Amgen AMG 386

Updated results at ESMO from a phase 2 study of AMG 386 combined with chemotherapy in advanced ovarian cancer found that patients treated with the higher dose of the drug lived for a median of 22.5 months, compared with 20.4 months for those given a lower dose, and 20.9 months for patients who received only the chemotherapy drug paclitaxel. Amgen said it has begun a phase 3 trial.

September 27,2010 AstraZeneca PLC zibotentan

AstraZeneca announces that a phase 3 study evaluating zibotentan for the treatment of men with metastatic castration resistant prostate cancer (CRPC)--the same patient population as Dendreon's Provenge--did not show a significant improvement in the primary endpoint of overall survival (OS). Based on the trial result, AstraZeneca said it planned no regulatory submissions for zibotentan "at this time". The trial, dubbed study 14, was part of a zibotentan ENTHUSE trial programme which includes two other ongoing studies in different CRPC settings. Full results of study 14 will be published in 2011.

September 27,2010 Seattle Genetics / Millennium brentuximab vedotin (SGN-35)

Seattle Genetics reports positive top-line data from a pivotal phase 2 trial of brentuximab vedotin (SGN-35) in relapsed and refractory Hodgkin lymphoma--75% of patients achieved an objective response, the primary endpoint of the trial. The median duration of response was greater than six months. The company says that a more complete data set will be presented at an upcoming scientific meeting. Seattle Genetics plans a BLA submission for SGN-35 in the first half of 2011.

September 24,2010 Yaupon Therapeutics Clearazide™ (topical mechlorethamine gel)

On Sept. 24, privately held Yaupon announces positive top-line results from the pivotal study of its lead product candidate, a proprietary topical mechlorethamine gel for early-stage cutaneous T-cell lymphoma (CTCL). The data show that the study achieved its primary and secondary endpoints. The product candidate has been granted Fast Track Status and Yaupon intends to file an NDA with the FDA later in 2010.

September 17,2010 Roche / Genentech Avastin® (bevacizumab)

The FDA delays an expected Sept. 17 decision on whether or not to revoke Avastin's conditional approval as a breast cancer treatment and extends their review of the drug by 3 months, until Dec. 17, due to additional data submitted by Genentech. The company submits additional data on two applications to expand Avastin's approved breast cancer uses to include combining the drug with other types of chemotherapy. On the heels of the FDA news, Avastin fails to extend disease-free survival in a trial of early colon cancer.

September 15,2010 BioCryst Pharmaceuticals forodesine

BioCryst posted weak results from two trials of its orally administered PHP inhibitor forodesine. Top-line data from a pivotal late-stage trial in cutaneous T-cell lymphoma (CTCL), whose main goal was complete or partial skin response, showed that only 11% of patients responded to forodesine and no patient achieved a complete response. Analysts said that the data wasn't good enough to secure FDA approval for the drug; the company said it is still accessing the feasibility of filing for marketing approval. Interim results from a phase 2 study of forodesine in chronic lymphocytic leukemia (CLL), whose goal was overall response rate, found partial response in three out of 25 patients. Final results from the CLL study are expected later in 2010 at an upcoming medical meeting.

September 13,2010 Seattle Genetics lintuzumab (SGN-33)

Seattle Genetics said it would halt development of lintuzumab after a phase 2b trial missed its primary endpoint and failed to prolong survival in previously treated elderly patients with acute myeloid leukemia (AML). SGEN's CEO said that details of the trial would be released at an upcoming medical meeting or published in a journal. The company said it would focus on its lead product candidate, brentuximab vedotin (SGN-35), for which data from two important clinical trials is expected within the next six weeks. Shares fell 13.5 percent.

September 10,2010 AstraZeneca PLC Faslodex® (fulvestrant) Injection

The FDA approved the 500mg dose of Faslodex, replacing the previously approved monthly dose of 250mg, for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. The approval was based on results of the Phase 3 CONFIRM trial, presented at SABCS in Dec. 2009, which demonstrated that Faslodex 500mg significantly increased median progression free survival to 6.5 months vs. 5.4 months with the 250mg dose.

August 25,2010 Roche / Genentech and ImmunoGen trastuzumab-DM1 (T-DM1)

The FDA denies giving a priority review to Roche's BLA, submitted in July 2010, for T-DM1 for advanced breast cancer on the basis of a single-arm phase 2 study. The move is likely to push the drug's launch back at least two years. Roche said it would continue with its ongoing phase 3 registrational T-DM1 trial, EMILIA, comparing T-DM1 with GlaxoSmithKline’s Tykerb plus capecitabine for a second-line indication, and expects to submit a new T-DM1 BLA in mid-2012.

August 19,2010 Bristol-Myers Squibb ipilimumab

BMY announces that the FDA has accepted, for filing and review, the Biologics License Application (BLA) for ipilimumab for the treatment of adult patients with advanced melanoma who have been previously treated. The company's application receives a priority review with a projected FDA action date of December 25, 2010. The filing is based on results from the primary analysis of the pivotal MDX010-020 Phase 3 trial, presented at ASCO in June 2010, which was the first randomized trial to show an improvement in survival for patients with advanced melanoma.

August 11,2010 Amgen Vectibix® (panitumumab)

In Phase 3 results that Amgen called "disappointing," Vectibix failed to meet the primary endpoint, overall survival, of a Phase 3 study testing the drug as a first-line treatment in combination with chemotherapy in squamous cell head and neck cancer. The median survival period for those taking Vectibix was 11.1 months in the trial, vs. nine months for chemotherapy alone, a difference not deemed statistically significant. Shares fell 3.8% in afternoon trading. The drugmaker plans to report detailed results from the study at the upcoming 35th ESMO meeting in October.

July 29,2010 Allos Therapeutics Folotyn(R) (pralatrexate injection)

Allos announces top-line results from a Phase 2b study testing Folotyn versus Roche/OSI's Tarceva in advanced non-small cell lung patients who had received one or two prior systemic treatments. Patients receiving Folotyn had a 16% reduction in the risk of death compared to Tarceva in the overall patient population. Positive trends in overall survival were observed favoring Foltyn in all other patient subgroups except patients with squamous cell carcinoma and patients previously treated with Lilly's Alimta. Folotyn won accelerated approval from the FDA late last year as the first and only FDA-approved treatment for peripheral T-cell lymphoma (PTCL).

July 26,2010 Onyx Pharmaceuticals carfilzomib

Onyx announces positive top-line results from a pivotal Phase 2b 003-A1 study of single-agent carfilzomib in severely ill multiple myeloma patients whose cancer had worsened after an average of five prior treatment regimens. The study found that 24% of patients, one out of four, responded to carfilzomib for a median duration of 7.4 months. The company's shares jumped 18%; Onyx said it planned to file for the indication based on the study's results and seek an accelerated six-month review from the FDA before the end of 2010. Full details of the trial, including side effects, weren't released, although Onyx said that the drug had been well-tolerated by patients. Onyx added the next generation proteasome inhibitor to its pipeline when it bought Proteolix in 2009.

July 20,2010 Roche AG / Genentech Avastin® (bevacizumab)

Roche's shares fell to their lowest level in trading in more than a year the day after an FDA advisory panel voted 12 to 1 to recommend that the agency revoke their approval of Avastin for the treatment of advanced breast cancer. The panel unanimously said that two follow-up trials, AVADO and RIBBON 1, taken together, failed to demonstrate enough clinically meaningful benefit for patients to warrant using it given the drugs' risks. The FDA will make a final decision on whether to revoke Avastin's provisional approval for the breast cancer indication, granted in Feb. '08, by Sept. 17.

July 01,2010 Novartis Afinitor® (everolimus)

A pivotal Phase 3 trial of Afinitor in patients with advanced pancreatic neuroendocrine tumors (NET) met its primary goal and significantly extended progression-free survival, more than doubling the time without tumor growth, for patients compared with placebo. Everolimus extended median progression-free survival from 4.6 to 11.0 months vs. placebo and reduced the risk of cancer progression by 65% for patients in the RADIANT-3 study. The data validated earlier studies. A final analysis of the trial is expected to be presented at the 2010 ESMO annual meeting in Milan, Italy in mid-October. Worldwide regulatory filings are planned for 2010.

June 17,2010 Novartis AG Tasigna® (nilotinib)

Following a priority review, the FDA approves Tasigna for newly diagnosed adults patients with Ph+ CML in chronic phase. The approval makes Tasigna the first new therapeutic option approved as a first-line treatment for CML since Glivec. The US approval was based on the results from the ENTESTnd phase 3 pivotal trial presented at ASCO; in that head-to-head study, 44% of patients taking the newer oral therapy Tasigna had a major molecular response compared with 22% for Glivec after 12 months. The response rate is an indicator usually associated with higher rates of long-term survival.

June 17,2010 sanofi-aventis Jevtana® (cabazitaxel) Injection

The FDA approves Jevtana in combination with prednisone for patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen. In the Phase 3 TROPIC study, the chemotherapy drug reduced the risk of death by 28% overall in men receiving it plus a steroid compared with men taking another chemotherapy drug plus a steroid. The company said that Jevtana is the first and only therapy to provide a significant survival benefit in the second-line treatment of one of the most difficult-to-treat populations. The ruling came more than three months ahead of the FDA's decision deadline of Sept. 30. Jevtana, administered intravenously, became available in the U.S. on July 19.

June 16,2010 Curis Inc. / Roche Holding AG GDC-0449

Curis's shares plunged 46% when its hedgehog pathway inhibitor failed to meet a primary goal based on topline results from a Phase 2 trial. GDC-0449 failed to extend the time of disease progression or death as a first-line treatment in metastatic colorectal cancer patients. The drug was tested in combination with Avastin and chemotherapy compared to the current standard of care. Curis said it has hopes for the drug in other cancer indications. Results from a Phase 2 study in advanced ovarian cancer are due in 2H '10, along with results from a pivotal Phase 2 trial in basal cell carcinoma in 2011. At ASCO, early-stage trial data was positive for the drug in treating pediatric brain tumors.

June 09,2010 Keryx Biopharmaceuticals perifosine

Final results from a Phase 2 study of perifosine in previously treated patients with advanced colorectal cancer confirmed a statistically significant improvement in both time to tumor progression (TTP) and overall survival (OS) for patients in the perifosine plus capecitabine arm (P-CAP) vs. those in the placebo plus capecitabine (CAP) arm. The Phase 3 X-PECT trial of perifosine in patients with advanced refractory colorectal cancer is currently enrolling patients.

June 08,2010 GTx Inc. Acapodene® (toremifene 80 mg)

Data from the TREAT 1 Phase 3 trial presented at ASCO demonstrated that toremifene 80 mg treatment had a more pronounced fracture reduction and better safety profile in men on androgen deprivation therapy for prostate cancer who were younger than age 80. For patients less than age 80 at enrollment, toremifene 80 mg treatment vs. placebo demonstrated a 79.5% reduction in the incidence of new vertebral fractures. GTx expects to initiate TREAT 2, the second Phase 3 trial by year end 2010.

June 08,2010 Sunesis Pharmaceuticals vosaroxin (formerly known as voreloxin)

Final clinical data from a phase 2 study of single agent vosaroxin in women with platinum-resistant ovarian cancer was presented during an oral session at ASCO. Data from the trial demonstrated encouraging, durable anti-tumor activity across all three dose cohorts, with the majority of patients achieving stable disease or an objective response. Sunesis said the promising data warrant further study in ovarian cancer in both the later stage, salvage setting, and in earlier lines of therapy.

June 08,2010 Ziopharm Oncology palifosfamide (Zymafos™ or ZIO-201)

Shares of Ziopharm climbed on Fri., May 21, a day after data from a mid-stage study of palifosfamide showed the effectiveness of the company's experimental therapy. The Phase 2 PICASSO study compared palifosfamide, or Zymafos, plus doxorubicin vs. doxorubicin alone in patients with soft-tissue sarcoma. The combination of palifosfamide plus doxorubicin almost doubled progression-free survival over the standard chemotherapy drug alone (7.8 months versus 4.4 months). A pivotal Phase 3 study of the drug in soft tissue sarcoma is anticipated to begin later in 2010.

June 08,2010 Amgen AMG 386

In one of Amgen's highlighted studies at ASCO, AMG 386, combined with paclitaxel, showed promising antitumor activity and extended progression-free survival in a Phase 2 trial of women with recurrent ovarian cancer. Median progression-free survival (PFS) was 7.2 months for the 10 mg/kg arm of the trial vs. 5.7 months for the 3 mg/kg arm and 4.6 months in the placebo group. Amgen plans to move the AMG 386 into a Phase 3 trial for recurrent ovarian cancer.

June 08,2010 Pfizer bosutinib

Pfizer presented data from a Phase 2 study of bosutinib in patients with Philadelphia chromosome positive chronic phase CML showing that patients who failed to benefit from or were unable to tolerate Gleevac (imatinib) and other tyrosine kinases responded to the experimental therapy, a dual Src and Bcr-Abl kinase inhibitor.

June 08,2010 Novartis Tasigna® (nilotinib)

Ahead of an ASCO oral presentation on June 7, Novartis issues a June 4 release announcing 18-month follow-up data from the Tasigna vs. Glivec trial in newly diagnosed Ph+ CML showing that Tasigna significantly surpasses Glivec in slowing disease progression in adult patients. In the Phase 3 ENESTnd study, the first head-to-head comparison of the two oral therapies, Tasigna produced deeper molecular responses and significantly reduced progression to advanced disease, resulting in fewer deaths due to CML. Tasigna is under priority review by the FDA for the indication.

June 08,2010 Eisai Oncology eribulin mesylate ("eribulin," also known as E7389)

Data from the global Phase 3 EMBRACE study released on June 6 showed that Eisai's chemotherapy drug eribulin significantly improved median overall survival vs. Treatment of Physician's Choice (TPC) in patients with locally recurrent or metastatic breast cancer who had previously received at least two chemotherapeutic regimens. Women who received eribulin survived a median of 2.5 months longer than patients who received TPC (overall survival of 13.12 months versus 10.65 months). The FDA has granted Eisai's application filed for approval of eribulin priority review with a decision expected by Sept. 30.

June 06,2010 Bristol-Myers Squibb ipilimumab

In phase 3 study results ipilimumab extended survival in patients with late-stage melanoma who had failed two previous therapies and kept about a quarter of them alive for two years--almost twice the proportion associated with standard treatments. The clinical trial is the first randomized study to find an improvement in survival for advanced melanoma, which has few treatment options. Bristol-Myers' said it would seek FDA approval for the immunotherapy this year.

June 06,2010 Celgene Revlimid® (lenalidomide)

Data from two separate Phase 3 studies (CALBG 100104 and IFM 2005-02) of Revlimid, presented during an oral session at ASCO, showed that when taken as maintenance therapy following stem-cell transplantation, the multiple myeloma drug reduced the risk of disease progression more than 50 percent in patients and kept the disease in check longer than for those patients who took a placebo.

June 06,2010 Nektar Therapeutics NKTR-102

About 48% of women with platinum-resistant/refractory ovarian cancer saw sustained benefits from treatment with NKTR-102 in a small Phase 2 study reported at ASCO. Twenty-three percent of patients on a dose schedule of once every three weeks saw substantial shrinkage in their tumors, and 38% saw a marked reduction in the ovarian cancer biomarker CA-125.

June 06,2010 Roche/Genentech Avastin® (bevacizumab)

In Phase 3 (GOG 0218) trial data presented during the ASCO Plenary Session, Avastin met its primary endpoint of progression-free survival (PFS) and slowed tumor growth by nearly 4 months when used for a long period of time in previously untreated women with advanced ovarian cancer. Roche said the results highlight the importance of continuing with Avastin after combining Avastin with chemotherapy in this setting.

June 06,2010 Pfizer crizotinib (PF-02341066)

In a Phase 1/2 study of crizotinib, Pfizer's oral lung cancer drug reduced tumor size significantly in 57% of NSCLC patients with an ALK gene aberration and stopped the progression of the disease in 87% of those in the study. The gene flaw occurs in only about 5% of lung cancer patients.

June 06,2010 Novartis Zometa® (zoledronic acid)

In a Phase 3 trial (Myeloma IX) of newly diagnosed multiple myeloma patients adding Zometa to first-line chemotherapy vs. oral clodronate added to chemotherapy significantly improved overall survival, demonstrating a 5.5 month survival improvement. Zometa also reduced the relative risk of skeletal-related events, or SREs, associated with multiple myeloma 24% more than clodronate.

June 06,2010 Eli Lilly & Co. Erbitux® (cetuximab)

A Phase 3 study of patients carrying the normal KRAS gene with early-stage colon cancer found that there was no survival advantage when they were given Erbitux plus chemotherapy, compared with those given chemotherapy alone. The study results came as a surprise to researchers since Erbitux has been found to improve survival in the same group of KRAS-bearing patients with advanced colon cancer.

June 05,2010 Delcath Systems Percutaneous Hepatic Perfusion (PHP) for cancer-related liver metastases

Delcath's PHP drug delivery system helped melanoma patients whose cancer had spread to their liver live more than three times as long as patients treated with best available care. The major side effect seen in the Phase 3 trial was bone marrow suppression. Positive study results in progression-free survival (PFS), previously released on April 21, saw Delcath's stock soar 24%.

June 05,2010 ArQule ARQ 197

A Phase 2 trial of ARQ 197 plus Tarceva in previously treated EGFR inhibitor-negative patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) improved overall survival by 24% compared to Tarceva and a placebo, but the results were not statistically significant. ARQ197 was most effective in tumors that were non-squamous, had mutations in a gene called KRAS, or did not have genetic mutations of the epidermal growth factor receptor.

June 05,2010 Pharmacyclics PCI-32765

Pharmacyclics announced interim data from a small Phase 1 trial evaluating PCI-32765 as a monotherapy for patients with relapsed aggressive non-Hodgkin's lymphoma (NHL). The latest results showed about 49% of patients, or 17 out of 35 evaluated in the trial, responding to the drug.

June 05,2010 Bristol-Myers Squibb Sprycel® (dasatinib)

A Phase 3 study found that Sprycel is superior to the standard first-line drug, Gleevec, in patients newly diagnosed with chronic myeloid leukemia (CML). Complete cytogenic response--or the disappearance of the CML cells, or tumor--occurred in 77% of Sprycel patients after 12 months compared with 66% for Gleevec, a result considered statistically significant. Sprycel also topped Gleevec in major molecular response rate--46% with Sprycel vs. 28% with Gleevec. The 519-patient study looked at response of the cancer after 12 months, a potential predictor of what long-term patient survival could be with Sprycel, now approved only as a second-line treatment for CML.

June 05,2010 Roche/Genentech & Biogen Idec Rituxan® (rituximab)

Data from the Phase 3 PRIMA study found that the risk of cancer returning in lymphoma patients was cut by half when Rituxan was used as a maintenance treatment for two years. PRIMA enrolled patients with previously untreated advanced follicular lymphoma who responded to initial treatment with Rituxan plus chemotherapy. The study suggests that lymphoma might be treated like a chronic disease with patients maintaining remission through chronic therapy. Roche and Biogen have filed in the US and Europe to extend the drug's current label to include such "maintenance" treatment for patients with advanced follicular lymphoma.

June 05,2010 Novartis AG Afinitor® (everolimus)

Afinitor helped shrink benign brain tumors in patients with the rare genetic disease, tuberous sclerosis. The small 28-patient study showed a significant reduction in the size of tumors in 75% of patients after six months of treatment with the cancer drug.

June 05,2010 Roche/Genentech and Immunogen trastuzumab-DM1 (T-DM1)

Preliminary results from a Phase 1b/2 trial (TDM4373g) combining T-DM1 and Roche's pertuzumab in women with advanced HER2-positive breast cancer showed that the two experimental drugs shrank tumors in nine of 23 women whose cancer had worsened after a median of eight prior treatments with other drugs including Herceptin and Tykerb. Updated safety and preliminary efficacy results on the drug combination from additional patients was reported to be promising. Roche plans to file for accelerated FDA approval of TDM-1, based on positive Phase 2 data, in 2H '10.

June 05,2010 Amgen Inc. Prolia™ (denosumab)

Denosumab delayed fractures and complications longer than Novartis AG's Zometa in men whose prostate cancer had spread to their bones, based on Phase 3 study results presented at ASCO. The data showed that men taking denosumab went an average of 20.7 months before their initial bone complication, vs. 17.1 months for men on Zometa. Denosumab, which will be marketed as Prolia, won FDA approval on June 1 as an osteoporosis treatment for postmenopausal women. Amgen is also seeking approval from U.S. regulators to use the drug to prevent skeletal problems in cancer patients.

May 26,2010 GTx Inc. toremifene 20 mg

GTx's shares sank 35% after Phase 3 topline results were reported for its experimental prostate cancer drug in men with a high grade, premalignant lesion of the prostate. Incidence of prostate cancer was lower in men receiving toremifene 20 mg compared to placebo but not "statistically significantly different". The company might conduct a bigger trial after reviewing the data. GTx said it would focus on a 2nd final-stage trial of toremifene's 80 mg dose to prevent bone loss in prostate cancer patients that GTx is conducting to satisfy the FDA.

April 29,2010 Dendreon Corp. Provenge® (sipuleucel-T)

Dendreon's stock shot up 27%, closing at $50.18 on the Nasdaq, as Provenge's historical FDA approval on April 29 made news. It was the biggest gain in a year, and the announcement also boosted the stocks of companies developing similar products. The first cancer immunotherapy product ever approved in the U.S was greenlighted on the basis of data from the phase 3 IMPACT trial which showed that Provenge extended the lives of men with castration-resistant prostate cancer by an average 4.1 months. The new therapy is indicated for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). The FDA refused to approve Provenge in 2007 despite an outside advisory committee's unanimous vote in favor of the treatment.

April 21,2010 Delcath Systems Percutaneous Hepatic Perfusion (PHP) for cancer-related liver metastases

Delcath's stock soared 24% as Phase 3 data was released on its PHP system in patients with melanoma whose cancer has metastasized to the liver, and the late-stage trial met its main goal. The study compared the experimental technology, used with the chemotherapy drug melphalan, to best alternative care. The best alternative care arm showed progression-free survival of only around 2 months compared with the PHP arm, which showed an expected progression-free survival of 7 months.

April 16,2010 Genentech / OSI Pharmaceuticals Tarceva® (erlotinib) tablets

The FDA approves Tarceva's use as a first-line maintenance treatment in advanced non-small cell lung cancer (NSCLC) after chemotherapy fails. The once-daily pill had been previously approved in 2004 for patients with NSCLC whose cancer worsens after chemotherapy, and for pancreatric cancer. On Dec. 16, FDA advisors had voted 12-1 against expanding the drug's label because they argued that only a “modest improvement" of one-month prolonged survival was shown over the three-month survival benefit when Tarceva was taken as a maintenance treatment.

April 13,2010 ChemGenex Pharmaceuticals Ltd. Omapro™ (omacetaxine mepesuccinate) for injection

ChemGenex announces receipt of a Complete Response Letter from the FDA regarding its NDA for Omapro as a chronic myeloid leukemia (CML) treatment for adults who have failed prior therapy with imatinib and have the Bcr-Abl T315I mutation. The company says that regulators haven't requested a new study or asked for increased patient enrollment into Omapro's pivotal study. ChemGenex indicates that the main issues underlying the FDA's non-approval are those raised at the March 22 ODAC meeting and the company will work with the agency to address those matters. ChemGenex said at an April 9th FDA meeting it discussed a path forward to develop a diagnostic test for the T315I mutation that would meet the agency's requirements, another issue that impeded Omapro's approval.

April 10,2010 Cell Therapeutics, Inc. proposed trade name Pixuvri™ (pixantrone dimaleate) injection

Ahead of an April 23 PDUFA action date, the FDA issues a Complete Response Letter to CTI regarding its NDA for Pixuvri, formally rejecting its approval for relapsed or refractory aggressive NHL. Earlier on March 22, an FDA advisory panel had unanimously recommended against the drug's approval. CTI says in a statement that the agency's decision is the result of previous concerns raised at the March ODAC meeting and that the FDA has recommended an additional trial to demonstrate pixantrone's safety and effectiveness. The company plans to pursue an expanded access program for pixantrone while it conducts the additional study in NHL. Shares closed on April 8th at 63 cents.

March 29,2010 GenVec Inc. TNFerade™

GenVec's stock fell about 75% on the news that the company was discontinuing its pivotal phase 3 trial of TNFerade in advanced pancreatic cancer based on data from a second interim analysis. Patients treated with TNFerade combined with radiation and chemotherapy had only an 8% reduction in the risk of death compared to treatment with radiation and chemotherapy alone. The first interim analysis in Nov. 2008 demonstrated a survival benefit of 25% for patients treated with the therapy plus standard of care compared to treatment with standard of care alone.

March 22,2010 Cell Therapeutics Inc. proposed trade name Pixuvri™ (pixantrone dimaleate) injection

An FDA advisory panel voted 9-0 against recommending CTI's Pixuvri for approval as a treatment for advanced, aggressive non-Hodgkin's lymphoma patients who have failed two previous therapies. CTI's stock experienced its biggest decline in 12 years based on the ODAC meeting's outcome. Advisors, who reviewed data from the phase 3 EXTEND study of 140 patients, said that the single incomplete trial of pixantrone was insufficient to support approval. Regulators had raised concerns earlier in FDA briefing documents in February concerning the small number of patients in the study, pixantrone's heart safety and the lack of an SPA. The FDA is expected to make an approval decision by April 23.

March 22,2010 ChemGenex Pharmaceuticals Ltd. Omapro™ (omacetaxine mepesuccinate) for injection

ChemGenex stock plunged 37% when an FDA advisory panel rejected the company's leukemia drug Omapro for approval in a 7-1 vote. Panel members said that the proposed treatment for chronic myeloid leukemia (CML) patients with a T315I genetic mutation should not be approved until the company shows a "well-characterized" genetic test that will accurately identify patients likely to benefit and that the test should be required and reviewed by the FDA before approval of the drug. The company plans to meet with the FDA on April 9 to review its strategy for having the drug approved.

March 20,2010 A.P. Pharma APF530

U.S. health regulators refused to approve APF530 as a treatment for chemotherapy-induced nausea and vomiting (CINV), citing concerns regarding the drug's administration system, and asked for more studies. A.P. Pharma's stock plunged 64% to 75 cents in premarket trade. If approved, APF530 would have been the second drug in the market to treat delayed onset CINV, and competed with Eisai's Aloxi (palonosetron) in the U.S. APF530's commercial launch in 2010 is now unlikely.

March 07,2010 sanofi-aventis proposed trade name Jevtana™ (cabazitaxel)

In phase 3 results from the TROPIC study, presented on Mar. 5 at the ASCO-GU symposium, sanofi's experimental chemotherapy drug increased survival by 30% in men with metastatic castration-resistant prostate cancer (mCRPC) whose tumours no longer responded to standard treatment and whose cancer worsened despite treatment with docetaxel-based chemotherapy. The trial showed median overall survival of 15.1 months for patients treated with cabazitaxel in combination with prednisone, a steroid, compared to 12.7 months for patients treated with a combination of the prostate cancer drug, mitoxantrone, and prednisone. Sanofi plans to seek approval for the new drug in both the U.S. and Europe later in 2010; cabazitaxel was recently fast-tracked by the FDA.

March 06,2010 Dendreon Corp. Provenge® (sipuleucel-T)

Updated results from Provenge's pivotal phase 3 IMPACT trial, presented at the ASCO-GU Symposium on Mar. 5, demonstrated that the experimental cancer vaccine improved three-year survival of men with advanced prostate cancer by 40% compared with a placebo--patients receiving Provenge lived an average of 4.1 months longer than those on a placebo. The results confirmed earlier data showing that the drug improved survival by 38% in men whose prostate cancer had stopped responding to hormone blockers. Dendreon's stock showed some volatility just before the data came out on Mar. 4 when rumors speculated that another FDA advisory panel would meet to review the drug prior to its scheduled PFUDA date of May 1. Both the company and the FDA confirmed that no meeting was planned.

February 24,2010 Novelos Therapeutics NOV-002

Novelos' shares sank more than 80% as the company announced that a pivotal phase 3 trial of NOV-002 in advanced non-small cell lung cancer (NSCLC) failed to meet its primary endpoint of improvement in overall survival. The study evaluated lead product NOV-002 in combination with first-line chemotherapy versus first-line chemotherapy alone. Novelos cited inaccurate statistical modeling leading up to the testing as a cause for the trial's failure, and said it expects to present detailed trial results at a scientific conference later in 2010. The company had hoped to establish a new standard of care in lung cancer treatment with NOV-002, which is an older cancer drug.

February 19,2010 Roche / Genentech & Biogen Idec Rituxan® (rituximab)

Roche's drug was approved by the FDA for a new use—in combination with chemotherapy for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL). The approval was based on data from two phase 3 studies, CLL8 and REACH, in both patient populations respectively, which showed that Rituxan with chemotherapy significantly extended the time people with CLL lived without the disease worsening compared to chemo alone. In one late-stage study, first-time CLL patients who received Rituxan and chemotherapy went eight months longer before their disease worsened than those who just got chemotherapy.

February 08,2010 Amgen Inc. proposed brand name Prolia™(denosumab)

Denosumab met both its primary and secondary endpoints in a pivotal phase 3 trial testing it against Zometa in the treatment of bone metastases in advanced prostate cancer patients. Denosumab significantly delayed the time to first skeletal related event and significantly reduced first-and-subsequent skeletal related events compared to Zometa; both results were statistically significant. The study is the final of three pivotal trials in advanced cancer patients investigating denosumab's potential in bone metastases, which will form the basis for an application to be filed with regulators later in 2010.

February 05,2010 Strativa Pharmaceuticals (Par Pharmaceuticals Cos.) Zuplenz® (ondansetron) oral soluble film

The FDA issues a Complete Response Letter regarding the company's NDA for Zuplenz for the prevention of nausea and vomiting associated with chemotherapy, radiotherapy and surgery. Due to an agency-wide restriction on foreign travel in India, the FDA said it was unable to perform an inspection of sites for a bioequivalence study, and could not approve the application at the current time.

January 29,2010 GlaxoSmithKline Tykerb® (lapatinib)tablets

The FDA grants accelerated approval on Jan. 29 for a new combination regimen using Tykerb as a first-line, all-oral treatment for women with metastatic breast cancer. The approval broadens Tykerb's label for its use in combination with Novartis Femara to treat hormone-positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated. Women receiving a combination of the two oral drugs more than doubled the time they lived without the cancer progressing compared with those receiving Femara alone.

January 25,2010 Spectrum Pharmaceuticals Fusilev® (levoleucovorin) for injection

Spectrum announces that the FDA has requested additional data on Fusilev, although the company says that regulators did not ask for any additional efficacy studies. In Oct. '09, the FDA issues a Complete Response Letter regarding the company's sNDA for Fusilev's use in advanced metastatic colorectal cancer patients in combination with other treatments. The agency said that the drug did not show non-inferiority to the standard treatment leucovorin. Spectrum plans to submit the additional data to the FDA in 3Q10.

2009

Date Company Product Event
December 17,2009 Photocure ASA Hexvix® (hexaminolevulinate)(US product name pending)

Hexvix, a diagnostic imaging agent used as an adjunct to white light cystoscopy in the detection of non-muscle invasive bladder cancer, is approved pending FDA approval of the PMA for the blue light cystoscopy system that will be used with Hexvix on the US market and final agreements between Photocure and the FDA on labeling, and post-marketing commitments. Photocure expects the pending issues to be agreed upon with the FDA within 1H10.

December 16,2009 Genentech / OSI Pharmaceuticals Tarceva® (erlotinib) tablets

An FDA advisory panel voted 1 to 12 against Tarceva's approval for its proposed indication as a first-line maintenance treatment in patients with non-small cell lung cancer. Patients receiving Tarceva had a median progression-free survival of 12.3 weeks compared with 11.1 weeks for those on placebo. The panel said the benefit of using Tarceva earlier in treatment than currently called for was modest considering other available treatment options. The PDUFA date for the drug's sNDA, originally January 18, 2010, was pushed back to April 18, 2010 on January 15.

December 14,2009 Vion Pharmaceuticals Inc. Onrigin™ (laromustine) Injection

On the heels of a Dec. 12 PDUFA date, Vion announces receipt of a Complete Response letter from the FDA regarding its NDA for Onrigin as a single agent for remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myelogenous leukemia (AML). On Sept. 1, an ODAC panel had voted unanimously against approval. As anticipated, the FDA asks for an additional randomized study prior to approval to define the efficacy and safety of the drug, among other issues. Vion says it does not have sufficient capital to fund the additional study and that it will evaluate its strategic alternatives.

December 12,2009 Roche Holding AG Herceptin® (trastuzumab)

New long-term follow up-data from two large pivotal Phase 3 studies (N9831 and BCIRG 006) evaluating adjuvant Herceptin in HER2-positive early-stage breast cancer showed that Herceptin reduced the risk of cancer returning by about one-third in women compared to patients receiving chemotherapy alone. In both studies, at least 80% of women receiving one year of Herceptin were alive free of the disease at 5 years follow-up.

December 12,2009 Roche Holding AG / ImmunoGen trastuzumab-DM1 (T-DM1)

In a pivotal phase 2 study of patients with very advanced HER2-positive breast cancer, T-DM1 shrank tumors in 33% of advanced breast cancer patients who were unresponsive to treatment with other drugs such as Herceptin and Tykerb. Patients also went an average of 7.3 months before their tumors began to grow again. T-DM1, a second-generation version of Herceptin, consists of Herceptin linked to a tumor-killing chemotherapy payload developed by ImmunoGen.

December 11,2009 Roche Holding AG Avastin® (bevacizumab)

Key data announced at SABCS from the phase 3 RIBBON-2 study of Avastin in advanced breast cancer showed that women who received the drug in combination with commonly used chemotherapies as second-line treatment had a 28% improvement in progression free survival compared to chemotherapy alone.

December 08,2009 Ariad Inc. AP24534

Interim data from a phase 1 study of Ariad's AP24534 showed that the multi-targeted kinase inhibitor was well-tolerated and had beneficial anti-tumor activity in treating patients with advanced blood cancers resistant to other therapies. The trial is studying patients who failed prior inhibitor therapy for chronic myeloid leukemia (CML). AP24534 could represent an important treatment option for CML patients who have become resistant or refractory to currently available therapies such as Gleevec, Sprycel and Tasigna.

December 07,2009 Onyx Pharmaceuticals / Proteolix carfilzomib

Onyx's carfilzomib, acquired when the company bought Proteolix, significantly reduced multiple myeloma in 45% of patients in a phase 2b study ("003") presented at ASH. Patients enrolled in the trial didn't respond to as many as three previous therapies. The drug also showed an improved side effects profile and produced good response rates in patients. Onyx hopes to gain accelerated approval for carfilzomib as a treatment for multiple myeloma in 2010, pitting it against Velcade, a current treatment for the disease.

December 07,2009 Celgene Corp. Revlimid® (lenalidomide)

Data from the phase 3 MM-015 study of Revlimid in newly diagnosed patients with multiple myeloma at ASH showed that the drug reduced the risk of disease progression by 50%. The data also showed that patients who were treated with Revlimid as a follow-on, maintenance therapy, had a 75% reduction in the risk of their disease progressing compared with those who took an induction regimen alone.

December 07,2009 Cephalon Inc. Treanda® (bendamustine HCI) for Injection

In data reported at ASH, Treanda plus Rituxan stalled the spread of certain lymphomas--all forms of NHL--20 months longer than a four-drug chemotherapy cocktail paired with Rituxan, the current standard of care. The study could support Treanda's use, in combination with Rituxan, as a first-choice therapy for patients with the slow-growing blood cancers. The drug is currently approved for patients with non-Hodgkin's lymphoma who haven’t responded well to previous therapies and those with chronic lymphocytic leukemia.

November 16,2009 Poniard Pharmaceuticals picoplatin

A day after Poniard said that picoplatin does not significantly improve survival for advanced lung cancer patients in its pivotal phase 3 SPEAR trial, the company reports positive data on the drug as a treatment for colorectal cancer.

November 16,2009 Genta Inc. Genasense® (oblimersen sodium) Injection

Results from more detailed preliminary data presented on Nov. 16 of the phase 3 AGENDA trial of Genasense in patients with advanced melanoma did not show a statistically significant benefit for the co-primary endpoint of progression-free survival, nor for secondary endpoints of overall response or disease-control. The other co-primary endpoint in AGENDA, overall survival, is too early to evaluate, the company said. AGENDA passed a futility analysis, and the Independent Data Monitoring Committee recommended that the trial continue to completion. Pending funding, Genta indicated that the trial should continue until the overall survival analysis could be conducted, which the company anticipates could take place in the second half of 2010.

November 05,2009 Gloucester Pharmaceuticals Istodax® (romidepsin) Injection

Almost a week ahead of its Nov. 12 PDUFA date, the FDA approves Gloucester's romidepsin, an HDAC inhibitor, for the treatment of cutaneous T-cell lymphoma (CTCL), a type of non-Hodgkin's lymphoma. On Sept. 2, an FDA advisory panel voted in favor of approving the therapy.

November 03,2009 GTx Inc. Acapodene® (toremifene 80 mg)

GTx announces on Nov. 2 that it has received a Complete Response Letter from the FDA regarding its NDA for toremifene 80 mg to reduce fractures in men with prostate cancer on androgen deprivation therapy (ADT). U.S. regulators cited clinical deficiencies and asked for more data. GTx has requested a meeting with the FDA to determine the appropriate next steps.

October 30,2009 Schering-Plough Corp. PegIntron® (peginterferon alfa-2b) injection

Schering-Plough announced on Oct. 30 that the FDA issued a Complete Response Letter in the company's bid to market PegIntron as a treatment for certain skin cancer patients who also undergo surgery. Schering did not say what the FDA's concerns were. On Oct. 5, an FDA advisory panel narrowly backed PegIntron's additional use in patients with advanced melanoma amid concerns about the drug's considerable side-effects, and also questioned if the drug actually helped people live longer or just increased the time before cancer recurred.

October 28,2009 GlaxoSmithKline / Genmab A/S Arzerra™ (ofatumumab)

Ahead of its Oct. 31 PDUFA date, Arzerra receives accelerated approval as a treatment for chronic lymphocytic leukemia in patients who have already received other forms of chemotherapy, which are no longer effective at controlling the condition.

October 19,2009 Amgen proposed brand name Prolia™(denosumab)

D-mab's approval hit a snag when the FDA bypassed the drug's PDUFA decision date of Oct. 19 requesting more information concerning both the company's osteoporosis and cancer-related BLAs. Amgen announced in an Oct. 21 earnings release that the FDA declined to approve the drug in treating bone loss from hormone therapy in breast cancer and prostate cancer patients, saying it wants more safety information coming from additional clinical trials. Despite the delay, analysts said they expect the drug to ultimately be approved.

October 19,2009 GlaxoSmithKline proposed brand name Votrient™ (pazopanib) tablets

The FDA approves Votrient, a new oral drug to treat kidney cancer, following an FDA advisory panel's unanimous endorsement in favor of the drug's approval on Oct. 5.

October 18,2009 sanofi-aventis Elitek® (rasburicase)

The FDA approves Elitek for use in adults with leukemia, lymphoma or solid tumors who are receiving anti-cancer therapy expected to cause tumor lysis syndrome (TLS), a life-threatening condition, or subsequent elevations of plasma uric acid (PUA), a side effect of cancer treatment.

October 18,2009 Merck & Co. Gardasil® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

Gardasil, already indicated for females ages 9 to 26 to prevent cervical cancer, wins FDA approval for preventing genital warts in males in the same age group. An FDA advisory panel voted earlier on Sept. 9 to expand the vaccine's label for use in boys and young men.

October 18,2009 GlaxoSmithKline Cervarix™ Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)

The FDA finally approves GSK's Cervarix for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25) after an FDA advisory panel greenlights the vaccine on Sept. 9.

October 08,2009 Spectrum Pharmaceuticals, Inc. Fusilev® (levoleucovorin) for injection

Spectrum's stock fell the most in 18 months after the FDA refused to approve Fusilev for a new use in combination with other treatments for advanced metastatic colorectal cancer. U.S. regulators didn't think that the company's submission proved the drug to be as good as the currently available therapy. The company expects to meet with the FDA on their sNDA in January 2010.

October 06,2009 Genzyme Corp. Clolar® (clofarabine)

Genzyme receives a Complete Response Letter regarding its sNDA for Clolar's potential use in adult patients with acute myeloid leukemia (AML) and requests a meeting with the FDA to discuss a path forward for the drug's approval. An ODAC panel issued a negative review of Clolar on Sept. 1, saying that the company should be required to conduct a larger, comparison study to prove that the drug is safe and effective in older patients.

September 24,2009 Allos Therapeutics Folotyn™ (pralatrexate injection)

The FDA grants accelerated approval for Folotyn for use as a single agent for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL), making it the first and only drug approved for the indication.

September 10,2009 Centocor Ortho Biotech Products, LP / Zeltia SA (Yondelis); Centocor Ortho Biotech Products, LP (Doxil) Yondelis™ (trabectedin) and Doxil® (doxorubicin HCI liposome injection)

J&J’s Centocor unit announces the receipt of Complete Response Letters for both its sNDA for Doxil in combination with docetaxel for advanced breast cancer and its NDA for Yondelis in combination with Doxil for relapsed ovarian cancer. An ODAC panel voted against recommending both drugs for their proposed indications on July 15 after weighing the modest treatment effects seen in patients treated with each therapy versus the drugs' considerable toxicity. The company says it will respond to the FDA as quickly as possible regarding both drugs.

September 04,2009 Spectrum Pharmaceuticals Inc. Zevalin® (ibritumomab tiuxetan)

Spectrum receives FDA approval to expand the use of its non-Hodgkin's lymphoma (NHL) drug Zevalin as a first-line consolidation therapy for NHL patients on Sept. 4 a little ahead of its PDUFA date.

August 02,2009 Roche / Genentech Avastin® (bevacizumab)

Genentech / Roche announce that Avastin has been approved by the FDA in combination with interferon alfa-2a therapy for patients with first-line metastatic renal cell carcinoma. The approval is based on the global phase 3 AVOREN study, which showed that previously untreated patients with mRCC who received Avastin plus interferon-alfa had a 67% increase in progression-free survival (PFS) compared to those who received interferon-alfa alone.

July 20,2009 Eli Lilly & Co. / ImClone Systems & Bristol-Myers Squibb (Erbitux); Amgen (Vectibix) Erbitux® (cetuximab); Vectibix® (panitumumab)

The companies announce U.S. product labelling revisions for Erbitux and Vectibix, their respective EGFR monoclonal antibody inhibitors. The revisions are based on retrospective analyses across multiple randomized clinical trials suggesting that anti-EGFR mAbs are not effective for the treatment of patients with metastatic colorectal cancer who test positive for K-ras mutations. The decision follows a Dec. '08 FDA ODAC meeting where the clinical utility of the K-ras gene as a predictive biomarker in patients with mCRC treated with the anti-EGFr antibodies was discussed.

July 16,2009 BioDelivery Sciences International, Inc. / Meda AB Onsolis™ (fentanyl buccal soluble film)

The FDA approves Onsolis, an opioid pain reliever prescribed for certain cancer patients to manage "breakthrough" pain. Regulators also say they'll require a "risk evaluation and mitigation strategy" (REMS) due to Onsolis' drug class.

July 06,2009 Eli Lilly & Co. Alimta® (pemetrexed for injection)

Alimta wins approval as the first maintenance treatment for advanced lung cancer in patients who have nonsquamous non-small cell lung cancer (NSCLC) whose disease hasn't progressed after four cycles of platinum-based first-line chemotherapy, expanding on its FDA-approved indications.

May 05,2009 Roche / Genentech Avastin® (bevacizumab)

The FDA grants accelerated approval for Avastin in patients with glioblastoma with progressive disease following prior therapy.

March 30,2009 Novartis Afinitor® (everolimus)

Afinitor, taken orally, is approved as the first treatment for patients with advanced kidney cancer after failure of treatment with either Sutent (sunitinib) or Nexavar (sorafenib).

2008

Date Company Product Event
December 17,2008 Novartis Pharmaceuticals Gleevec® (imatinib mesylate)

Gleevac expands it use and is approved in the post-surgical treatment of adult patients following complete surgical removal of Kit (CD117)-positive gastrointestinal stromal tumors (GIST).

December 15,2008 Genzyme Corp. Mozobil® (plerixafor injection)

Mozobil, a stem cell transplant drug, is approved for use in non-Hodgkin’s lymphoma and multiple myeloma patients.

November 20,2008 GlaxoSmithKline / Ligand Promacta® (eltrombopag olamine)

GSK's oral drug is approved for short-term use in patients with chronic immune thrombocytopenic purpura (ITP).

October 31,2008 Cephalon Treanda®(bendamustine HCI) for Injection

Treanda is approved for non-Hodgkins lymphoma (NHL), its second FDA approval in '08.

September 14,2008 ProStrakan Group plc Sancuso® (Granisetron Transdermal System)

Sancuso, a patch for the prevention of chemotherapy-induced nausea and vomiting (CINV), wins FDA approval.

August 22,2008 Amgen Nplate® (romiplostim) Nplate, a once-weekly injection for the long-term treatment of chronic immune thrombocytopenic purpura (ITP), is approved.
August 21,2008 Celgene Vidaza® (azacitidine)

Vidaza receives expanded FDA approval, reflecting new overall survival data in patients with higher-risk myelodysplastic syndromes (MDS).

June 20,2008 Millennium / Takeda Velcade® (bortezomib) for Injection

Velcade wins FDA approval as a first-line treatment for multiple myeloma, widening its use beyond second-line therapy.

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