Bayer's Stivarga Gets Priority Review from FDA
Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced today that the U.S. Food and Drug Administration (FDA) granted priority review to the New Drug Application (NDA) filed at the end of August 2012 for Stivarga^® (regorafenib) tablets to treat patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with two kinase inhibitors. The submission was based upon data from the pivotal, global Phase III GRID study.
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