Bayer's Stivarga Gets Priority Review from FDA

Bayer HealthCare and Onyx Pharmaceuticals, Inc.

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.