Correction: Onyx-Bayer-Cancer Drug
NEW YORK (AP) — In a story Aug. 30 about Onyx Pharmaceuticals and Bayer's cancer drug regorafenib, The Associated Press reported erroneously that the Food and Drug Administration has agreed to conduct a six-month review of the drug as a treatment for gastrointestinal cancer. The FDA is conducting a six-month review of the drug as a treatment for colorectal cancer.
A corrected version of the story is below:
Onyx says Bayer files for cancer drug approval
Onyx partner Bayer files for gastrointestinal cancer drug approval; FDA starts new review
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 is also reviewing regorafenib as a treatment for colorectal cancer. It has agreed to complete its review in six months and is scheduled to make a decision in October. 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.