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FDA approves Bayer's regorafenib

September 28, 2012 1:30 AM UTC

FDA approved Stivarga regorafenib from Bayer AG (Xetra:BAYN) to treat previously treated metastatic colorectal cancer (mCRC) a month ahead of the product's Oct. 27 PDUFA date. Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) has co-promotion rights in the U.S. to the dual acting signal transduction (DAST) inhibitor of multiple kinases and is eligible for a 20% royalty on worldwide sales. Bayer said the product will be available immediately at a wholesale acquisition cost of $9,350 per 28-day cycle. In clinical trials, the median duration of Stivarga treatment was 12 weeks, which would translate into a cost of about $28,000. ...