FDA Considers Approval of Fusilev for Colorectal Cancer

The FDA has notified Spectrum Pharmaceuticals that it will decide whether to approve Fusilev (levoleucovorin) for colorectal cancer within 6 months. The current indications for Fusilev include osteosarcoma and methotrexate-related toxicity. In October 2009, the FDA rejected a request to approve Fusilev for colorectal cancer based on lack of efficacy. The manufacturer submitted additional data in support of its application to the FDA on October 29, 2010.