Bayer HealthCare and Onyx Pharmaceuticals announced that the FDA has granted priority review designation to Bayer HealthCare’s New Drug Application (NDA) filed end of April 2012 for the oral multikinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer whose disease has progressed after approved standard therapies. Under the Prescription Drug User Fee Act (PDUFA), the FDA will complete its review within 6 months from the receipt of the NDA submission, rather than the standard 10-month review cycle.
The submission was based upon data from the pivotal, global phase III CORRECT study. Regorafenib is being investigated in clinical trials for its potential to treat patients with various tumor types. ■