Bayer Granted FDA Priority Review Designation for New Colorectal Cancer Drug

Bayer HealthCare and Onyx Pharmaceuticals have announced that FDA has granted priority review designation to Bayer's new drug application for the oral multi-kinase inhibitor regorafenib, according to a news release.

 

Regorafenib is intended to treat patients with metastatic colorectal cancer whose disease has progressed after standard therapy.

 

FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists. FDA completes a priority review within six months of receiving the new drug application rather than the standard 10-month review cycle.

 

The application for regorafenib was filed at the end of April.

 

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