Onyx says Bayer files for cancer drug approval

Onyx partner Bayer files for gastrointestinal cancer drug approval; FDA starts 6-month review

Associated Press

NEW YORK (AP) -- Onyx Pharmaceuticals Inc. and Bayer HealthCare said Thursday that Bayer has filed for U.S. marketing approval of a gastrointestinal cancer drug the companies are developing.

Bayer asked the Food and Drug Administration to approve the drug regorafenib as a treatment for gastrointestinal stromal tumors, which mostly occur in the stomach or small intestine.

The companies want to market the drug for patients who have cancer that is inoperable or has metastasized, and whose cancer has progressed despite prior treatment.

The FDA has agreed to conduct a six-month review of the drug, meaning the agency should announce a decision by late February or early March. The agency usually takes 10 months to review applications for new drugs but conducts six-month priority reviews for drugs that treat a condition that has few or no existing treatment options.

Shares of Onyx Pharmaceuticals, based in South San Francisco, Calif., lost $1.09 to $70.83 in afternoon trading. Bayer is a unit of Bayer AG, headquartered in Germany.

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