Priority Review Granted for Regorafenib for Metastatic Colorectal Cancer

Bayer HealthCare and Onyx announced that the FDA has granted priority review of the New Drug Application (NDA) 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 submission was based upon data from the pivotal, global Phase 3 CORRECT study.

Regorafenib is an investigational oral multi-kinase inhibitor and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.

For more information visit www.onyx.com or www.bayer.com.