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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