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Too Bad For Tookad: FDA Adcom Votes Against Steba&rsquo...

(BioWorld) Feb 26, 2020 - Citing what it called poor study design and execution coupled with a lack of follow-up data, the FDA’s Oncologic D...

First-Line Cyramza in NSCLC Gets Split Decision From FD...

(MedPage Today) Feb 27, 2020 - An FDA advisory panel was split on Wednesday over whether to recommend approval of ramucirumab (Cyramza) as an ...

Featured Content

Bradley McGregor, MD, discusses Checkmate-214 investigating nivolumab + ipilimumab in 1st line renal cell carcinoma patients

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center and Michael Jain, MD, Assistant Member, Department of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, discuss the role of CAR-T and the treatment of lymphoma and off-the-shelf CAR-T

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center and Lori Leslie, MD, Medical Oncologist, Regional Cancer Care Associates, discuss clinical highlights in the treatment of CLL

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center and Michael Yang, MD, Department of Lymphoma and Myeloma, Division of Cancer Medicine, MD Anderson, discuss recent clinical advances in mantle cell lymphoma

A panel of three experts, led by Dr. Brian Slomovitz of Sylvester CCC, discussed the expanded role of PARP inhibitors and how the new targeted agents, niraparib, olaparib, and rucaparib, are setting a new paradigm in the treatment of advanced ovarian cancer. Topics covered included a look at three landmark trials from ESMO and how they've influenced treat...

Some of the high points and practice-changing data at ASCO GI 2020 were from trials such as IMbrave150 and BEACON, and news on a liquid biopsy from GRAIL with the potential for the early detection of GI cancers. However, there were disappointing outcomes presented in San Francisco too. Read on for the full scoop, plus a selection of videos on some of the ...

ASH Presidential Symposium presenters provided a number of examples as to how big data is impacting hematology research and the delivery of personalized healthcare. The FDA's Dr. Amy Abernethy talked about the role of data, analytics and policy in optimizing healthcare and what some of the agency's plans are in these areas. Privacy concerns and data qual...

Podcasts

Colorectal Cancer – Zev Wainberg MD, and Robert Figlin, MD, discuss recent clinical advances in colorectal cancer from ASCO GI

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Mantle Cell Lymphoma (MCL) – Michael Wang MD, and Robert Figlin, MD, discuss recent clinical advances in mantle...

02/03/20

Chronic Lymphocytic Leukemia (CLL) – Lori Leslie MD, and Robert Figlin, MD, discuss clinical highlights in the ...

01/10/20

Acute Myeloid Leukemia (AML) - Courtney DiNardo MD, and Robert Figlin, MD, discuss the latest clinical developments i...

01/10/20

CAR-T and Lymphoma – Michael Jain, MD, and Robert Figlin, MD, discuss the role of CAR-T in the treatment of lym...

12/21/19

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Kylee Martens, MD, on the role of rasburicase in managing TLS in patients with renal dysfunction

Catherine Diefenbach, MD, regarding the unmet needs in the management of follicular lymphoma

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February 2020 Edition

A panel of three experts, led by Dr. Brian Slomovitz of Sylvester CCC, discussed the expanded role of PARP inhibitors and how the new targeted agents, niraparib, olaparib, and rucaparib, ...

February 2020 Edition

Some of the high points and practice-changing data at ASCO GI 2020 were from trials such as IMbrave150 and BEACON, and news on a liquid biopsy from GRAIL with the potential for the early ...

February 2020 Edition

ASH Presidential Symposium presenters provided a number of examples as to how big data is impacting hematology research and the delivery of personalized healthcare. The FDA's Dr. Amy Aber...

Blog

Dean's Digest - ASCO GU 2020

Feb 19, 2020

Major themes which emerged from ASCO GU 2020 included a plethora of studies utilizing various permutations of targeted therapies along with immunotherapy and/or c...

Dean's Digest - ASCO GI 2020

Jan 28, 2020

ASCO GI 2020 was held in San Francisco January 23-25. Numerous studies involving Phase 1/2 evaluations of new drugs in gastrointestinal (GI) malignancies were rep...

What to Look for at ASH 2019

Nov 26, 2019

During a pre-meeting webinar devoted to ASH 2019, experts highlighted important advances and practice-changing studies to be presented in Orlando, FL, December 7-...

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Oncology Events Calendar

March 2 - 7, 2020

For Caregivers: Care Coordination for Your Loved One Living with Cancer and Other Health Problems (CancerCare Connect® Education Workshop)

[by phone or online via webcast]

April 23 - 24, 2020

OBR Radar

Top 5 Market Moving Events

Date	Company and Product
Feb 27	BeiGene Ltd., Brukinsa™ (zanubrutinib) February 27, 2020 is the FDA action date for BeiGene's zanubrutinib for mantle cell lymphoma after at least one prior line of therapy. Brukinsa (brand name), a Bruton’s tyrosine kinase (BTK) inhibitor, was granted accelerated approval by the FDA for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy on Nov. 14, 2019. The accelerated approval was supported by clinical trial results showing a high response rate of tumor shrinkage — 84% of patients saw tumor shrinkage with the therapy. The data was based on efficacy results from two single-arm clinical trials, with independent review committee (IRC)-assessed overall response rate (ORR) per 2014 Lugano Classification as the primary endpoint. Across both trials, Brukinsa achieved an ORR, or the sum of complete responses and partial responses, of 84%. It was the first FDA approval for BeiGene. Continued approval for the indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. BeiGene announced on Aug. 21, 2019 that the FDA had accepted the company’s NDA for zanubrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and granted the application a Priority Review.
Mar 10	Bristol-Myers Squibb, Opdivo® (nivolumab) + Yervoy® (ipilimumab) The company announced on Nov. 11, 2019 that the FDA had accepted for priority review its sNDA and granted Breakthrough Therapy Designation for Opdivo in combination with Yervoy as a treatment for patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. The application will be given a Priority Review and has been assigned a PDUFA date of Mar. 10, 2020. The application is based on data from the Opdivo plus Yervoy cohort of the ongoing phase 1/2 CheckMate -040 study with data from that study presented at ASCO 2019. The Opdivo plus Yervoy cohort the trial is evaluating the safety and efficacy of the I-O combination in patients with previously treated advanced HCC. Primary endpoints include safety and tolerability and objective response rate (ORR).
Mar 31	AstraZeneca PLC , Imfinzi® (durvalumab) AstraZeneca said on Nov. 29, 2019 that the FDA had accepted a sBLA and granted priority review for Imfinzi, an anti-PDL1 antibody, for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC). A PDUFA date is set for the first quarter of 2020. The sBLA was based on positive results from the phase 3 CASPIAN trial published in The Lancet showing that durvalumab in combination with standard-of-care (SoC) chemotherapy (etoposide with either cisplatin or carboplatin) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) vs. SoC alone. The risk of death was reduced by 27%, with median OS of 13.0 months for durvalumab plus chemotherapy vs. 10.3 months for SoC.
Mar 31	Amgen , AMG 119 According to JPMorgan analysts, results in small cell lung cancer (SCLC) from the lead CAR-T in Amgen's pipeline, AMG 119, should be forthcoming toward the end of the first quarter of 2020. AMG 119 is one of a small group of DLL3-targeting therapies in development. DLL-3 is expressed in more than 80% of tumors in patients with SCLC. The readout is important not only in validating DLL3 as a target but also in the quest to extend the use of CAR-Ts in immunotherapy beyond blood cancers into solid tumors like lung cancer.
Apr 30	Sanofi , Isatuximab Sanofi said on July 10, 2019 that the FDA had accepted for review its BLA for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). The FDA target action date is Apr. 30, 2020. Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor. The BLA is based on positive results from ICARIA-MM, a pivotal phase 3 trial of isatuximab in patients with RRMM. The trial is the first positive randomized phase 3 to evaluate an antibody in combination with pomalidomide and dexamethasone. Results were presented at 2019 ASCO. Isatuximab has been designated an orphan drug by both U.S. and European regulators.