U.S. Food and Drug Administration has granted priority review to the new drug application filed by Bayer HealthCare, a subsidiary of Bayer AG (BYR.L), and Onyx Pharmaceuticals Inc. (ONXX) for Stivarga tablets to treat patients with metastatic and gastrointestinal stromal tumors.
The submission was based upon 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, 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.
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