FDA Accepts Spectrum's sNDA for Colorectal Cancer Indication
Thu, 03/26/2009 - 4:41am
Spectrum Pharmaceuticals, Inc. announced today that it received notification that the FDA has accepted for filing and review the supplemental New Drug Application (sNDA) for FUSILEV(TM) (levoleucovorin) for Injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal (PDUFA) date for the sNDA is October 8, 2009. The FDA approved FUSILEV on March 7, 2008 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. In December 2008, FUSILEV was listed in the National Comprehensive Cancer Network(R) (NCCN) Drugs and Biologic Compendium(TM) to be used in combination with high-dose methotrexate for the treatment of bone cancer (osteosarcoma and dedifferentiated chrondrosarcoma), and the NCCN Clinical Practice Guidelines in Oncology(TM) in Colon Cancer and Rectal Cancer were updated to reflect that FUSILEV is available in the United States.