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FDA grants Bayer’s Stivarga NDA priority review

Thursday, November 1, 2012 11:49 AM

Bayer HealthCare and Onyx Pharmaceuticals, a biopharmaceutical company based in South San Francisco, announced today that the FDA has granted priority review to the New Drug Application (NDA) for Stivarga (regorafenib) tablets.

The NDA for Stivarga is 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 on data from the pivotal, global phase III GRID study.

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.

This priority review follows the recent FDA approval of Stivarga for the treatment of patients with metastatic colorectal cancer 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.

Stivarga is a Bayer compound developed by Bayer and jointly promoted with 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.

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