Spectrum Pharma Hits Fusilev Roadblock At FDA

IRVINE, Calif. (AP) — Spectrum Pharmaceuticals Inc. said Friday the Food and Drug Administration 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.

Shares of Spectrum fell 91 cents, or 14.7 percent, to $5.30 in premarket trading. The stock has ranged from 55 cents to $10 over the past year.