FDA approves Spectrum's FUSILEV Injection to treat metastatic colorectal cancer

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Supplemental New Drug Application for FUSILEV^® (levoleucovorin) Injection. Unlike the currently available lyophilized product, this approval is for a "Ready-to-Use" formulation of FUSILEV^® (levoleucovorin) for Injection.

"We are pleased that the FDA has approved the 'Ready-to-Use' (RTU) formulation of FUSILEV^®," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "As the name implies, the RTU formulation provides an additional option for physician and medical staff use. The RTU formulation requires no reconstitution, and is of a higher strength than the currently available lyophilized formulation."

FUSILEV^® (levoleucovorin) for Injection 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. FUSILEV^® is currently under review by the FDA for use in advanced metastatic colorectal cancer. The Prescription Drug User Fee Act (PDUFA) action date for the supplement is April 29, 2011.