News briefs: Bayer's Stivarga and AstraZeneca's Faslodex

30 October 2012

German drug major Bayer (BAYN: DE) and US partner Onyx Pharmaceuticals (Nasdaq: ONXX) said yesterday that the US Food and Drug Administration granted priority review for their New Drug Application 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.

Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the USA. 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 (The Pharma Letter September 28).

Study of Faslodex in hormone receptor positive breast cancer

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