Spectrum Pharmaceuticals Inc. (SPPI)

Oncology Corporate Profile

Stock Performance

7.1400
-0.1000

HQ Location

11500 South Eastern Ave., Suite 240
Henderson, NV 89052

Company Description

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.

Website: http://www.spectrumpharm.com

Brand Generic Indication
Beleodaq®belinostatBeleodaq® 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®melphalanEvomela® 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®pralatrexateFolotyn® 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®levoleucovorinFusilev® 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 injectionMarqibo® 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 tiuxetanZevalin 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
  • Generic
  • Investigational
Brand / Product Class Area of Study Phase Partnership
SPI-2012granulocyte colony-stimulating factor (GCSF)Breast CancerIII
SPI-2012granulocyte colony-stimulating factor (GCSF)Chemotherapy-induced neuropeniaIII
EOquinp® / apaziquonealkylating agentNon-invasive Bladder cancerIIIAllergan, Inc.
Folotyn® / pralatrexateantifolateCutaneous T-cell Lymphoma (CTCL)III
Folotyn® / pralatrexateantifolatePeripheral T-cell Lymphoma (PTCL)III
Marqibo® / vincristine OPTISOME®liposomal vincristineNon-Hodgkin's Lymphoma (NHL)III
Zevalin® / ibritumomab tiuxetanCD20-directed radiotherapeutic antibodyDiffuse large B-cell Lymphoma (DLBCL)IIICell Therapeutics
ortataxeltaxane2nd line metastatic Breast cancer (taxane refractory)II
lucanthonetopoisomerase inhibitorBrain metastases from Non Small Cell Lung Cancer (NSCLC)II
poziotinibpan-her inhibitorBreast CancerII
lucanthonetopoisomerase inhibitorGlioblastoma Multiforme (GBM)II
ozarelix / SPI-153luteinizing hormone releasing hormone agonistHormone dependent Prostate cancerII
SPI-1620endothelin B receptor agonistNon Small Cell Lung Cancer (NSCLC)II
belinostatHDAC inhibitorNon Small Cell Lung Cancer (NSCLC)II
satraplatinplatinum chemotherapy agent (oral)Non Small Cell Lung Cancer (NSCLC)II
belinostatHDAC inhibitorPeripheral T-cell Lymphoma (PTCL)II
Folotyn® / pralatrexateantifolate2nd line metastatic Non-Hodgkin's Lymphoma (NHL)II
Folotyn® / pralatrexateantifolate2nd line metastatic transitional cell Bladder cancerII
Marqibop® / vincristine OPTISOME®liposomal vincristine1st line metastatic MelanomaII
Zevalin® / ibritumomab tiuxetanCD20-directed radiotherapeutic antibodyFollicular Non-Hodgkin's Lymphoma (f-NHL)IICell Therapeutics
RH1small molecule chemotherapeutic agentNon-Hodgkin's Lymphoma (NHL)I
menadione topical lotionprotein tyrosine phosphatase (PTP) inhibitor menadione (vitamin K3) with potential EGFR-& ErbB2/HER2-activating activitiesSupportive CareI
elsamitrucintopoisomerase inhibitorVarious cancer typesI
MTRN-2696vinka alkaloidVarious cancer typesI
RH1small molecule chemotherapeutic agentVarious cancer typesI
SPI-1620endothelin B receptor agonistVarious cancer typesI
Alocrest® / vinorelbine OPTISOME®liposomal vinorelbineHodgkin's LymphomaI
Alocrest® / vinorelbine OPTISOME®liposomal vinorelbineNon-Hodgkin's Lymphoma (NHL)I
Alocrest® / vinorelbine OPTISOME®liposomal vinorelbineVarious cancer typesI
Brakiva® / topotecan OPTISOME®liposomal topotecanBreast CancerI
Brakiva® / topotecan OPTISOME®liposomal topotecanOvarian cancerI
Brakiva® / topotecan OPTISOME®liposomal topotecanSmall Cell Lung Cancer (SCLC)I
Folotyn® / pralatrexateantifolateCutaneous T-cell Lymphoma (CTCL)I
Folotyn® / pralatrexateantifolateNon Small Cell Lung Cancer (NSCLC)I
Folotyn® / pralatrexate (+ gemcitabine)antifolateNon-Hodgkin's Lymphoma (NHL)I
Marqibo® / vincristine OPTISOME®liposomal vincristineVarious cancer typesI
SPI-205lipid suspension of leteprinimChemotherapy-induced neuropathyPreclinical

View additional information on product candidates here »

Source: http://www.spectrumpharm.com

Recent News Headlines

Spectrum Pharma, FDA and the Buried Truth About a Bladder Cancer Drug Meeting

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.

Spectrum Bladder Cancer Drug Not Effective: U.S. FDA Panel

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.

Immune Drug for Deadly Skin Cancer Shows Long-Term Survival

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.

Preserving Fertility In Women Receiving Cancer Treatment

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.

AstraZeneca Asthma Drug Shows Positive Results

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.

UnitedHealth Will Drop Out Of Most ACA Exchanges

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.

QIAGEN Partners to Develop Novel Companion Diagnostic in Lung Cancer

4/14/2016 11:02 am

(QIAGEN) Apr 13, 2016 - Collaboration with Mirati Therapeutics targets MET gene mutations to personalize treatment.

Breast Cancer Resistance to CDK4/6 Inhibitors Arises in Many Ways

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.

FDA Grants Spectrum Pharmaceuticals Approval of EVOMELA™ (melphalan) for Injection

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.

Spectrum Pharmaceuticals Initiates Phase 2 Breast Cancer Trial for Poziotinib, a Novel Pan-HER Inhibitor

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.

Foundation Medicine Announces First-Ever Public Release of Broad Pediatric Data From FoundationCORE™ to Accelerate the Development of Precision Medicine Strategies for Pediatric Cancers

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.

Spectrum Pharmaceuticals Announces FDA’s Acceptance of NDA Filing for EOquin® (apaziquone for intravesical instillation)

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.

Sun Hopes Cut-Price Generic Gleevec Will Win Third Of U.S. Market

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.

Spectrum Pharmaceuticals Begins Enrolling Patients in Registrational Trial of SPI-2012, a Novel, Long Acting G-CSF in Patients with Breast Cancer

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.

BLA for Adalimumab Biosimilar Accepted for Review

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).

Spectrum Pharmaceuticals Announces Agreement with FDA on the Special Protocol Assessment (SPA) for the Registrational Trial of SPI-2012, a Novel, Long Acting G-CSF in Patients with Breast Cancer

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.

Spectrum Pharmaceuticals and Onxeo Announce Complete Response in 67% of Patients with Peripheral T-Cell Lymphoma in Combination of Belinostat (Beleodaq®) and Standard CHOP

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).

Spectrum Pharma Resubmits EVOMELA NDA; PDUFA Date May 9

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.

Spectrum Pharmaceuticals Submits Phase 2 Breast Cancer Protocol to FDA as Part of an Investigational New Drug (IND) Application for Poziotinib

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.

Spectrum Pharmaceuticals Submits Phase 2 Breast Cancer Protocol to FDA as Part of an Investigational New Drug (IND) Application for Poziotinib

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.

Spectrum Pharmaceuticals Initiates Apaziquone Pivotal Trial for the Treatment of Non-Muscle Invasive Bladder Cancer (NMIBC) Following SPA Agreement

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.

Spectrum Says U.S. FDA Declines to Approve Evomela for Injection

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.

Spectrum Pharmaceuticals Receives Complete Response Letter (CRL) from U.S. Food and Drug Administration (FDA) for EVOMELA™ (melphalan) for Injection

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).

N-of-One Selected by Spectrum Health to Provide Clinical Interpretation for 50-Gene Hot-Spot Solid Tumor Panel

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.

Spectrum Pharmaceuticals Announces Agreement with FDA on the Special Protocol Assessment (SPA) for the Upcoming Apaziquone Phase 3 Trial in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC)

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.

Experiment In Coordinated Care For Medicare Failed To Show Savings

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.

U.S. Indoor Tanning Rates Are Dropping, But Still High

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.

Siteman Cancer Center Earns Highest Rating From Federal Cancer Institute

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.

Increases in Cancer Screening May Reflect Removal of Financial Barriers in Affordable Care Act

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.

Former Rep. LaTourette Files Claim Over Missed Cancer

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.

Massive Bio Introduces Cancer Genomics Advisory Services for Community Oncologists

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.

Myriad Significantly Advances the myChoice(R) HRD(TM) Companion Diagnostic Test

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.

Novartis Presents New Data on 21 Medicines and 11 Investigational Compounds at ASCO and EHA

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.

Lymphoma Pattern Reassuring With Anti-TNF in RA

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.

ELCC 2015 News: Detection of EGFR T790M Mutation From Circulating Tumour DNA in Urine of Patients with Metastatic NSCLC

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.

Spectrum Pharmaceuticals Presents New Data on EVOMELA(TM) (CE-Melphalan), at the Annual Meeting of the American Pharmacists Association (APhA) in San Diego, Highlighting Stability

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.

Smartwatches Might Cause Cancer, Says Article Based on ‘Expert’ Who Pushes Holistic Breast Cancer Treatments

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.

U.K. Regulators Grant Early Access to Merck Skin Cancer Drug, but Where Is Northwest Bio?

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.

AcelRx Says FDA Calls for Additional Trial on Zalviso

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.

Spectrum Pharma Announces FDA Acceptance of CE-Melphalan NDA

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.

FDA is Sued by Otsuka For ‘Unlawfully’ Widening the Market for Abilify

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.

Spectrum Pharmaceuticals In-Licenses Poziotinib, a Novel pan-HER Inhibitor With Clinical Activity in Several Solid Tumors, From Hanmi Pharmaceuticals

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.

Valeant to Buy Salix in $10.1 Billion Deal

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.

Looking For That Fruit or Vegetable That Might Prevent Cancer?

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.