FDA Plans Faster Review Of Onyx-Bayer Cancer Drug

The FDA will review Onyx and Bayer's application for the colorectal cancer drug candidate regorafenib in six months instead of the usual 10.

SOUTH SAN FRANCISCO, Calif. (AP) — Onyx Pharmaceuticals Corp. and Bayer HealthCare said Thursday that the Food and Drug Administration will conduct a faster review of their colorectal cancer drug candidate regorafenib.

The companies said the FDA agreed to conduct a priority review, meaning it will review Onyx and Bayer's application in six months instead of the usual 10. Bayer filed for marketing approval of regorafenib in late April, meaning the FDA could make a decision in late October. The FDA sometimes conducts faster reviews ofdrugs that treat a condition that has few or no existing treatment options.

Onyx and Bayer want to market regorafenib as a treatment for metastatic cancer in patients whose disease has progressed after previous treatment.

Shares of Onyx Pharmaceuticals fell $1.09, or 1.6 percent, to $65.30 in morning trading.

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