New Drug Application for Regorafenib for the Treatment of Metastatic Colorectal Cancer Submitted by Bayer
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced that Bayer HealthCare has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the oral multi-kinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer (mCRC). Regorafenib is a Bayer compound, and Onyx will receive a royalty on global net sales of regorafenib in oncology.
The submission is based on the results of the pivotal, global Phase 3 CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial. Results from the study were first presented at the Annual Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO-GI) in January 2012 and will be presented at the upcoming ASCO annual meeting in Chicago, IL (USA) in early June 2012.
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