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FDA Has Granted Priority Review To NDA For Regorafenib, Reveals Onyx Pharma

Onyx Pharmaceuticals Inc (ONXX), a global biopharmaceutical company, and Bayer Healthcare Pharmaceuticals Inc, have, on Thursday, jointly announced that the U.S Food and Drug Administration or the FDA, has granted priority review designation to the New Drug Application, or the NDA, for the oral multi-kinase inhibitor regorafenib.

The company further stated that Bayer Healthcare had filed the NDA at the end of April 2012 for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer whose disease has progressed after approved standard therapies.

The company stated that 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.

Onyx Pharmaceuticals further added that the FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists. Furthermore, the FDA will complete its review within six months from the receipt of the NDA submission, rather than the standard 10-month review cycle.

by RTT Staff Writer

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