FDA plans faster review of Onyx-Bayer cancer drug
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 of drugs 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.