Bayer HealthCare and Onyx Pharmaceuticals, Inc. announced today that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Stivarga (regorafenib) tablets for the treatment of patients with metastatic colorectal cancer (mCRC).
In September 2012, Stivarga was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. It was approved by the U.S. FDA for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate in February 2013.
Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the United States. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net sales of Stivarga in oncology.
The approval of Stivarga by the MHLW is based on data from the international multicenter pivotal Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial which evaluated regorafenib plus best supportive care (BSC) versus placebo plus BSC in patients with mCRC, whose disease has progressed after approved standard therapies. The CORRECT study included 20 sites in Japan.