Spectrum Pharmaceuticals (NasdaqGM: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, has announced that on Friday, October 29, 2010 it submitted a complete response to the "Complete Response" letter issued by the U.S. Food and Drug Administration (FDA), regarding its supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.
"We believe that the additional data we submitted will satisfy the requirements of the FDA," said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "We continue to expect a favorable regulatory decision."
The FDA requested additional data in support of the Company's sNDA filing for FUSILEV's use in advanced metastatic colorectal cancer, which has now been submitted. FDA has up to 60 days to formally accept the submission.
FUSILEV is currently FDA approved and marketed by Spectrum for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination, and of inadvertent overdosage of folic acid antagonists.
About FUSILEV® (levoleucovorin) for Injection
FUSILEV, a novel folate analog, is available in vials as freeze-dried powder. FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV has been marketed outside the United States by Wyeth, Sanofi-Aventis, Takeda, and others for more than 10 years.
Important FUSILEV® (levoleucovorin) for Injection Safety Considerations
FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Due to calcium content, no more than 16-mL (160-mg) of levoleucovorin solution should be injected intravenously per minute. FUSILEV enhances the cyto-toxicity of fluorouracil. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study. Allergic reactions were reported in patients receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy. FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.
Full prescribing information can be found at FUSILEV.
SPECTRUM PHARMACEUTICALS, INC.®, ZEVALIN®, and FUSILEV® are registered trademark of Spectrum Pharmaceuticals, Inc., and TURNING INSIGHTS INTO HOPE™, BELINOSTAT™ and the Spectrum Pharmaceutical logos are trademarks owned by or licensed to Spectrum Pharmaceuticals, Inc.
FUSILEV® sNDA Is Currently Under Review By The FDA For Use In Combination Chemotherapy In Advanced Metastatic Colorectal Cancer
FUSILEV Is Currently FDA Approved and Marketed by Spectrum For:
- Rescue After High-Dose Methotrexate Therapy in Osteosarcoma;
- To Diminish the Toxicity and Counteract the Effects of Impaired Methotrexate Elimination, and of Inadvertent Overdosage of Folic Acid Antagonists
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.