Bayer's Stivarga regorafenib Tablets New Drug Application Granted Priority Review by U.S. FDA for the Treatment of Patients with Gastrointestinal.

Bayer's Stivarga regorafenib Tablets New Drug Application Granted Priority Review by U.S. FDA for the Treatment of Patients with Gastrointestinal Stromal Tumors

By a News Reporter-Staff News Editor at Pharma Business Week Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced that the U.S. Food and Drug Administration (FDA) granted priority review to the New Drug Application (NDA) filed at the end of August 2012 for Stivarga() (regorafenib) tablets to treat patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with two kinase inhibitors. The submission was based upon data from the pivotal, global Phase III GRID study (see also Bayer HealthCare Pharmaceuticals Inc.).

The FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within six months from the receipt of the NDA submission, rather than the standard 10-month review cycle.

Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the U.S. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all future global net sales of Stivarga in oncology.

This priority review follows the recent FDA approval of Stivarga for the treatment of patients with metastatic colorectal cancer (mCRC) who had been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.

About Gastrointestinal Stromal Tumors (GIST) GIST is the most common form of sarcoma (a type of cancer that develops from certain tissues, like bone or muscle) involving the gastrointestinal tract. In the United States, it is estimated that there are approximately 4,000-5,000 new cases of GIST diagnosed each year, of which about 1,500 have already metastasized at diagnosis. GIST may not cause any symptoms and may be found incidentally when the doctor is looking for other problems.([1,2,3])

Keywords for this news article include: Bayer HealthCare Pharmaceuticals Inc., FDA Actions, Government Agencies, Offices and Entities.

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