Spectrum Pharma Hits Fusilev Roadblock at FDA
Fri, 10/09/2009 - 4:54am
IRVINE, Calif. (AP) — Spectrum Pharmaceuticals Inc. said Friday the FDA does not consider its drug Fusilev effective enough for approval as a colon cancer treatment and recommended a meeting. The company received a "complete response letter" from the agency, saying that in studies Fusilev was not proven to be "non-inferior" to — or as effective as — the chemotherapy treatment leucovorin. The agency recommended the company meet with FDA representatives to discuss options for moving the colon cancer program forward. Spectrum said it plans to promptly request a meeting. Fusilev is already approved by the FDA for several other uses, including the bone tumor osteosarcoma.