Bayer HealthCare announced today that it 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).
"Bayer HealthCare is pleased to have reached this development milestone in regards to filing with the FDA," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "This is an important step toward our goal of bringing new treatment options to people living with cancer."
The submission is based on the results of a pivotal, global Phase III 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.
Bayer has also submitted an application for European marketing authorization for regorafenib for the treatment of patients with mCRC.
Bayer HealthCare Pharmaceuticals Inc.