FDA grants priority review to the new drug application

Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the New Drug Application (NDA) filed end of April 2012 for the oral multi-kinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.

The FDA grants priority review to medicines that offer major advances in care or that provide a treatment where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA will complete its review within six months from the receipt of the NDA submission, rather than the standard 10-month review cycle.

“We welcome the priority review of regorafenib by the FDA as it supports our efforts to make regorafenib available as early as possible to patients who have exhausted available therapies and urgently need new options,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

The submission was based upon data from the pivotal, global Phase III CORRECT study. The trial showed that oral regorafenib plus best supportive care (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. Primary efficacy and safety data for this trial were first reported at the Annual Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO-GI) in January 2012 and additional data were presented at the ASCO Annual Meeting in June 2012.