Bayer's Stivarga Tablets Approved by FDA

Intended for U.S. Media Only -- Bayer HealthCare and Onyx Pharmaceuticals, Inc.

announced today that the U.S. Food and Drug Administration (FDA) approved Bayer's Stivarga® (regorafenib) tablets for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy).1 The approval of Stivarga is based on results from the pivotal Phase III study (CORRECT) that demonstrated improvement in overall survival (OS) and progression-free survival (PFS) compared to placebo in patients with mCRC whose disease had progressed after approved standard therapies.2,3