Bayer HealthCare (BYR.L, BAYRY.PK, BAYZF.PK) and Onyx Pharmaceuticals Inc. (ONXX) announced that the U.S. Food and Drug Administration or 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).
Bayer stated that the approval of Stivarga is based on results from the pivotal Phase III study or CORRECT that demonstrated improvement in overall survival or OS and progression-free survival or PFS compared to placebo in patients with mCRC whose disease had progressed after approved standard therapies.
Stivarga is a Bayer compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc. under which Onyx will receive a royalty on any future global net sales of Stivarga in oncology. Bayer and Onyx will jointly promote Stivarga in the United States, Bayer said.
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