FDA Considers Approval of Fusilev for Colorectal Cancer

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Article
Oncology & Biotech NewsDecember 2010
Volume 4
Issue 12

The FDA has notified Spectrum Pharmaceuticals that it will decide whether to approve Fusilev (levoleucovorin) for colorectal cancer within 6 months.

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.

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