Bayer HealthCare has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) and a New Drug Application to the U.S. Food and Drug Administration (FDA) for the oral multi-kinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer (mCRC).
“These submissions of regorafenib for metastatic colorectal cancer are a significant development milestone for this agent and a step forward in bringing a potential new treatment to patients with metastatic colorectal cancer who currently have no other options,” said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “We are encouraged by the improved overall survival seen in the CORRECT study and look forward to continuing discussions with the regulatory authorities.”
The submissions are supported by data from the 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. The study 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 results showed that regorafenib plus BSC significantly improved both overall survival and progression-free survival, compared to placebo plus BSC. In this trial, the safety and tolerability of regorafenib were generally as expected and no new or unexpected toxicity was observed.