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FDA approves Stivarga for GIST

February 26, 2013 1:32 AM UTC

FDA approved an NDA from Bayer AG (Xetra:BAYN) to expand the label of Stivarga regorafenib to include treatment of locally advanced, unresectable or metastatic gastrointestinal stromal tumors (GIST) in patients who have previously been treated with Gleevec imatinib and Sutent sunitinib. In September, FDA approved Stivarga to treat previously treated metastatic colorectal cancer (mCRC). Onyx Pharmaceuticals Inc. (NASDAQ:ONXX), which has U.S. co-promotion rights to the dual acting signal transduction (DAST) inhibitor of multiple kinases and is eligible for a 20% royalty on worldwide sales, was off $0.44 to $77.87 on Monday (see BioCentury Extra, Sept. 27, 2012). ...