Spectrum Pharmaceuticals Receives Complete Response Letter From FDA For FUSILEV(R) In Advanced Metastatic Colorectal Cancer

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 13 Oct 2009 - 4:00 PST

email to a friend   printer friendly   view / write opinions

Spectrum Pharmaceuticals (NasdaqGM: SPPI), a commercial-stage biotechnology company with a primary focus in oncology, announced that it received a Complete Response letter from 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.

The FDA stated in the Complete Response letter that the submission did not demonstrate that FUSILEV is non-inferior to leucovorin; and recommended that the Company meet with them to discuss options for continuing to seek approval of FUSILEV in advanced metastatic colorectal cancer. The Company plans to promptly request such meeting to discuss options for FUSILEV in this indication.

The FDA did not request any changes to the currently approved indications and package insert.

About FUSILEV® (levoleucovorin) for Injection

FUSILEV, a novel folate analog, is available in vials as freeze-dried powder. FUSILEV rescue is also indicated after high-dose methotrexate therapy in osteosarcoma. Additionally, FUSILEV is 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.

Full prescribing information can be found at http://www.FUSILEV.com.

Source
Spectrum Pharmaceuticals