Oncology Corporate Profile
Spectrum Pharmaceuticals is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of oncology and other drug candidates that meet critical health challenges. The Company’s pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease.
|Beleodaq_?||belinostat||Beleodaq is a histone deacetylase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.|
|Evomela_?||melphalan||Evomela is an alkylating drug indicated for:|
- Use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem)cell transplantation in patients with multiple myeloma
- The palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
|Folotyn_?||pralatrexate||FOLOTYN is a folate analogue metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated.|
|Fusilev??||levoleucovorin||Fusilev is a folate analog indicated for:|
_?? Rescue after high-dose methotrexate therapy in osteosarcoma.
_?? Diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
_?? Use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
Limitations of Use
Fusilev is not approved for pernicious anemia and megaloblastic anemias. Improper use may cause a hematologic remission while neurologic manifestations continue to progress.
|Marqibo??||vinCRIStine sulfate LIPOSOME injection||MARQIBO is indicated for the treatment of adult patients with Philadelphia chromosome_?_negative (Ph?) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following 2 or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified|
|Zevalin??||ibritumomab tiuxetan||Zevalin is a CD20-directed radiotherapeutic antibody administered as part of the Zevalin therapeutic regimen indicated for the treatment of patients with:|
?_ relapsed or refractory, low-grade or follcular B-ce11 non-Hodgkin's lymphoma (NI-IL).
?_ previously untreated follcular NHL who achieve a partial or complete response to first-line chemotherapy.
View additional information on commercial products here »
|Brand / Product||Class||Area of Study||Phase||Partnership|
|SPI-2012||granulocyte colony-stimulating factor (GCSF)||Breast Cancer||III|
|SPI-2012||granulocyte colony-stimulating factor (GCSF)||Chemotherapy-induced neuropenia||III|
|EOquinp_ / apaziquone||alkylating agent||Non-invasive Bladder cancer||III||Allergan, Inc.|
|Folotyn_ / pralatrexate||antifolate||Cutaneous T-cell Lymphoma (CTCL)||III|
|Folotyn_ / pralatrexate||antifolate||Peripheral T-cell Lymphoma (PTCL)||III|
|Marqibo_ / vincristine OPTISOME_||liposomal vincristine||Non-Hodgkin's Lymphoma (NHL)||III|
|Zevalin_ / ibritumomab tiuxetan||CD20-directed radiotherapeutic antibody||Diffuse large B-cell Lymphoma (DLBCL)||III||Cell Therapeutics|
|ortataxel||taxane||2nd line metastatic Breast cancer (taxane refractory)||II|
|lucanthone||topoisomerase inhibitor||Brain metastases from Non Small Cell Lung Cancer (NSCLC)||II|
|poziotinib||pan-her inhibitor||Breast Cancer||II|
|lucanthone||topoisomerase inhibitor||Glioblastoma Multiforme (GBM)||II|
|ozarelix / SPI-153||luteinizing hormone releasing hormone agonist||Hormone dependent Prostate cancer||II|
|SPI-1620||endothelin B receptor agonist||Non Small Cell Lung Cancer (NSCLC)||II|
|belinostat||HDAC inhibitor||Non Small Cell Lung Cancer (NSCLC)||II|
|satraplatin||platinum chemotherapy agent (oral)||Non Small Cell Lung Cancer (NSCLC)||II|
|belinostat||HDAC inhibitor||Peripheral T-cell Lymphoma (PTCL)||II|
|Folotyn_ / pralatrexate||antifolate||2nd line metastatic Non-Hodgkin's Lymphoma (NHL)||II|
|Folotyn_ / pralatrexate||antifolate||2nd line metastatic transitional cell Bladder cancer||II|
|Marqibop_ / vincristine OPTISOME_||liposomal vincristine||1st line metastatic Melanoma||II|
|Zevalin_ / ibritumomab tiuxetan||CD20-directed radiotherapeutic antibody||Follicular Non-Hodgkin's Lymphoma (f-NHL)||II||Cell Therapeutics|
|RH1||small molecule chemotherapeutic agent||Non-Hodgkin's Lymphoma (NHL)||I|
|menadione topical lotion||protein tyrosine phosphatase (PTP) inhibitor menadione (vitamin K3) with potential EGFR-& ErbB2/HER2-activating activities||Supportive Care||I|
|MTRN-2696||vinka alkaloid||Various cancer types||I|
|elsamitrucin||topoisomerase inhibitor||Various cancer types||I|
|RH1||small molecule chemotherapeutic agent||Various cancer types||I|
|SPI-1620||endothelin B receptor agonist||Various cancer types||I|
|Alocrest_ / vinorelbine OPTISOME_||liposomal vinorelbine||Hodgkin's Lymphoma||I|
|Alocrest_ / vinorelbine OPTISOME_||liposomal vinorelbine||Non-Hodgkin's Lymphoma (NHL)||I|
|Alocrest_ / vinorelbine OPTISOME_||liposomal vinorelbine||Various cancer types||I|
|Brakiva_ / topotecan OPTISOME_||liposomal topotecan||Breast Cancer||I|
|Brakiva_ / topotecan OPTISOME_||liposomal topotecan||Ovarian cancer||I|
|Brakiva_ / topotecan OPTISOME_||liposomal topotecan||Small Cell Lung Cancer (SCLC)||I|
|Folotyn_ / pralatrexate||antifolate||Cutaneous T-cell Lymphoma (CTCL)||I|
|Folotyn_ / pralatrexate||antifolate||Non Small Cell Lung Cancer (NSCLC)||I|
|Folotyn_ / pralatrexate (+ gemcitabine)||antifolate||Non-Hodgkin's Lymphoma (NHL)||I|
|Marqibo_ / vincristine OPTISOME_||liposomal vincristine||Various cancer types||I|
|SPI-205||lipid suspension of leteprinim||Chemotherapy-induced neuropathy||Preclinical|
View additional information on product candidates here »
9/19/2016 07:36 am
(TheStreet) Sept 16, 2016 - The FDA told Spectrum not to seek approval for its bladder cancer drug. Spectrum filed anyway but never told investors about the FDA warning.
9/15/2016 07:03 am
(Reuters) Sept 14, 2016 - Spectrum Pharmaceuticals Inc's experimental bladder cancer treatment apaziquone is not effective in delaying the time to recurrence of the disease, an advisory committee to the U.S. Food and Drug Administration concluded on Wednesday.
5/19/2016 12:01 pm
(CBS News/Associated Press) May 19, 2016 - A new kind of drug for the deadliest form of skin cancer helped some patients survive for at least three years, a study shows. It's a remarkable advance for patients who until recently faced dismal chances of living for more than a few months.
5/17/2016 01:00 pm
(The Jackson Laboratory) May 17, 2016 - Female cancer patients may be able to retain their fertility during radiation and chemotherapy through treatments that target the DNA damage response in oocytes.
5/17/2016 12:02 pm
(MarketWatch/Wall Street Journal) May 17, 2016 - AstraZeneca PLC reported positive results from two late-stage studies on a severe asthma treatment that it hopes will grab market share in an increasingly competitive area.
4/19/2016 02:02 pm
(Modern Healthcare) Apr 19, 2016 - UnitedHealth Group CEO Stephen Hemsley said Tuesday the health insurance and services conglomerate will pull out of most of its Affordable Care Act marketplaces. But the company won't bail on the exchanges completely and will sell individual plans in a “handful” of states.
4/14/2016 11:02 am
(QIAGEN) Apr 13, 2016 - Collaboration with Mirati Therapeutics targets MET gene mutations to personalize treatment.
3/28/2016 11:04 am
(AACR) Mar 28, 2016 - Breast cancer cells became resistant to therapeutics targeting CDK4/6, such as palbociclib (Ibrance), in multiple ways, and preclinical studies suggested different combinations of therapeutics may prevent and overcome the acquisition of resistance to these anticancer agents, according to new research.
3/15/2016 07:28 am
(Yahoo! Finance) Mar 15, 2016 - Evomela received FDA approval for two indications: high-dose conditioning treatment for multiple myeloma (MM) patients undergoing autologous stem cell transplantation (ASCT); palliative treatment of patients with MM who cannot take oral therapy.
3/7/2016 11:58 am
(Yahoo! Finance) Mar 7, 2016 - Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that the Company has initiated the planned Phase 2 clinical study for Poziotinib, its novel pan-HER inhibitor.
2/25/2016 12:00 pm
(Yahoo! Finance) Feb 25, 2016 - Foundation Medicine, Inc. today announced that the company will release to the public molecular profiles of pediatric cancers currently maintained as part of FoundationCore™, the company’s information knowledgebase.
2/19/2016 11:12 am
(StreetInsider) Feb 19, 2016 - Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced that the U.S. Food and Drug Administration (the “FDA”) has accepted the EOquin® (apaziquone for intravesical instillation) New Drug Application (NDA) for review.
2/2/2016 12:00 pm
(Reuters) Feb 1, 2016 - Sun Pharma launched a generic version of Novartis's leukaemia drug Gleevec on Monday in the United States and hopes to poach a third of sales in six months by pricing the copycat some 30 percent cheaper, Sun's North American chief executive said.
1/29/2016 12:02 pm
(Yahoo! Finance) Jan 29, 2016 - The study is being conducted under Special Protocol Assessment (SPA) agreement with the FDA; this registrational, randomized, controlled Phase 3 study (ADVANCE) will evaluate SPI-2012 as a treatment for chemotherapy-induced neutropenia in approximately 580 patients with breast cancer.
1/26/2016 12:05 pm
(Monthly Prescribing Reference) Jan 26, 2016 - Amgen announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).
12/16/2015 11:39 am
(TheStreet) Dec 16, 2015 - Registrational, randomized, active-controlled Phase 3 study (ADVANCE) will study SPI-2012 as a treatment for chemotherapy-induced neutropenia in approximately 580 patients with breast cancer; the company expects to start the pivotal trial soon and plans to complete enrollment in 2017.
12/6/2015 03:15 pm
(Yahoo! Finance) Dec 6, 2015 - Spectrum Pharmaceuticals and Onxeo S.A. today jointly announced the results from their Phase 1 combination trial of belinostat (Beleodaq®) with the CHOP (Cyclophosphamide, Hydroxyl-doxorubicin; Vincristine, and Prednisone) chemotherapy regimen as first-line treatment for newly diagnosed peripheral T-cell lymphoma (PTCL).
12/1/2015 12:43 pm
(Seeking Alpha) Nov 25, 2015 - In a regulatory filing, Spectrum Pharmaceuticals discloses that it has resubmitted its New Drug Application (NDA) to the FDA for Orphan Drug-tagged EVOMELA (melphalan) for the conditioning treatment prior to hematopoietic stem cell transplant in multiple myeloma patients or palliative treatment of multiple myeloma.
11/23/2015 11:52 am
(Yahoo! Finance) Nov 20, 2015 - Spectrum Pharmaceuticals announced today the Company has submitted an IND application to the U.S. Food and Drug Administration (FDA) and plans to initiate a Phase 2 breast cancer study in the U.S. as soon as possible.
11/20/2015 12:19 pm
(Spectrum) Nov 20, 2015 - Spectrum Pharmaceuticals announced today the Company has submitted an IND application to the U.S. Food and Drug Administration (FDA) and plans to initiate a Phase 2 breast cancer study in the U.S. as soon as possible.
10/26/2015 11:31 am
(PharmiWeb.com) Oct 26, 2015 - Spectrum Pharmaceuticals, Inc. announced today the Company has initiated the planned Phase 3 clinical study for apaziquone, its novel, potent pro-drug, and the first patient was dosed on Friday, October 23, 2015.
10/23/2015 12:15 pm
(Reuters) Oct 23, 2015 - Biotechnology company Spectrum Pharmaceuticals Inc said the U.S. Food and Drug Administration declined to approve its Evomela injection to treat patients with multiple myeloma, a form of blood cancer that arises from plasma cells found in bone marrow.
10/23/2015 07:25 am
(Spectrum) Oct 23, 2015 - Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA).
8/18/2015 12:13 pm
(Yahoo! Finance) Aug 18, 2015 - N-of-One, Inc., the leader in clinical interpretation for precision medicine in oncology, today announced that it has signed an agreement with Spectrum Health to provide clinical interpretation for all cases sequenced on Spectrum Health’s 50-gene hot-spot solid tumor panel.
8/17/2015 11:36 am
(StreetInsider) Aug 17, 2015 - Spectrum Pharmaceuticals, Inc. announced today that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA) of the planned Phase 3 clinical trial of its novel, potent pro-drug, apaziquone.
7/28/2015 12:01 pm
(NPR/Shots blog) July 27, 2015 - The test aimed to help high-risk Medicare patients navigate the health care maze. But after three years, expected improvements in quality and savings failed to materialize.
7/27/2015 12:00 pm
(NCI/Cancer Currents Blog) July 24, 2015 - The number of people who tan indoors appears to be dropping, according to a new study from researchers at NCI and the U.S. Centers for Disease Control and Prevention (CDC). But using indoor tanning devices such as sunlamps, sunbeds, or tanning booths, which-increases-skin-cancer-risk, is still a common practice, they reported.
7/8/2015 12:00 pm
(St. Louis Post-Dispatch) July 8, 2015 - Siteman Cancer Center at Barnes-Jewish Hospital has earned the highest quality rating from the federal government’s principal agency for cancer research and training.
6/4/2015 12:00 pm
(American Cancer Society) June 4, 2015 - Screening for colorectal cancer increased in lower socioeconomic status (SES) individuals after 2008, perhaps reflecting the Affordable Care Act's removal of financial barriers to screening according to a new analysis.
5/29/2015 03:01 pm
(Seattle Times/Associated Press) May 27, 2015 - Former Rep. Steve LaTourette of Ohio, gravely ill with pancreatic cancer, has filed a claim against the government over the treatment he received from his Capitol doctors.
5/29/2015 03:00 pm
(Morningstar) May 29, 2015 - Massive Bio, a Manhattan-based startup, providing personalized advisory services for cancer patients, oncologists and oncology practices will begin offering its on-demand services publicly on June 1, following rigorous testing over the past three months.
5/29/2015 02:02 pm
(Myriad) May 29, 2015 - Myriad Genetics, Inc. today announced new clinical studies on its myChoice HRD companion diagnostic test at the 2015 American Society of Clinical Oncology annual meeting being held in Chicago, Ill.
5/27/2015 12:00 pm
(Novartis) May 27, 2015 - Novartis will highlight the strength of its expanded oncology portfolio in 21 medicines and 11 investigational compounds across more than 185 data presentations at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, May 29-June 2, and the Congress of the European Hematology Association (EHA), June 11-14.
5/5/2015 12:02 pm
(Medpage Today/The Gupta Guide) May 5, 2015 - No change in the pattern of lymphomas was seen among patients with rheumatoid arthritis (RA) treated with biologic therapies compared with those not receiving biologics, a large collaborative European analysis showed.
4/17/2015 11:05 am
(ESMO) Apr 17, 2015 - Monitoring circulating tumour DNA (ctDNA) is a promising technique that may provide clinicians with a faster, cheaper and less invasive way to evaluate the clinical status and response to therapy of cancer patients.
3/30/2015 12:06 pm
(Spectrum) Mar 30, 2015 - EVOMELA stability shown to be significantly longer than current Melphalan HCl for Injection in an oral presentation at the annual American Pharmacists Association (APhA) meeting.
3/20/2015 12:02 pm
(Washington Post/Speaking of Science) Mar 19, 2015 - Fitbits probably won't give people tumors, but articles like the one The New York Times ran this week might give me an ulcer.
3/11/2015 12:00 pm
(TheStreet) Mar 11, 2015 - Skin cancer patients in Britain can be treated with Merck's Keytruda before the cancer immunotherapy drug is approved there under a new early access plan announced Wednesday.
3/9/2015 01:00 pm
(Wall Street Journal) Mar 9, 2015 - AcelRx Pharmaceuticals Inc. said the U.S. Food and Drug Administration is calling for an additional clinical trial to assess risk tied to its experimental pain-management treatment, further delaying its potential approval and marketing.
3/9/2015 12:00 pm
(TheStreet) Mar 9, 2015 - Spectrum Pharma announced that its New Drug Application (NDA) for Captisol-Enabled Melphalan (CE-Melphalan), has been accepted by the U.S. Food and Drug Administration (FDA). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of October 23, 2015 for the CE-Melphalan NDA, which is 10 months from the filing date.
3/6/2015 12:00 am
(Wall Street Journal/Pharmalot blog) Mar 26, 2015 - It’s not every day that a drug maker complains the FDA widened a market for one of its drugs.
3/4/2015 12:26 pm
(Yahoo! Finance) Mar 4, 2015 - Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, today announced it has entered into a licensing agreement with Hanmi Pharmaceuticals for poziotinib, a drug being investigated for the treatment of cancer.
2/23/2015 12:03 pm
(Fox Business/Reuters) Feb 23, 2015 - Canada's Valeant Pharmaceuticals International Inc agreed to acquire gastrointestinal drugmaker Salix Pharmaceuticals Ltd in an all-cash deal valued at about $10.1 billion, the two companies said on Sunday.
2/19/2015 12:00 pm
(Washington Post) Feb 16, 2015 - Only about half of the recommendations on two internationally syndicated TV medical talk shows were supported by scientific evidence, according to a recent study in the journal BMJ.