FDA expands use of Bayer and Onyx' Stivarga for advanced GIST

The US Food and Drug Administration yesterday expanded the approved use of German drug major Bayer’s (BAYN: DE) Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.

Stivarga, which is co-marketed in the USA with Onyx Pharmaceuticals (Nasdaq: ONXX), was approved by the agency last fall to treat metastatic colorectal cancer (The Pharma Letter September 28, 2012). According to previous statements by Bayer, Stivarga has the potential for peak annual sales of 1 billion euros ($1.32 billion) with multiple approved uses.

Bayer recently announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted priority review to regorafenib in the treatment of patients with unresectable and/or metastatic GIST (TPL December 21, 2012). Bayer’s shares dipped 2.3% to 72.04 euros in early trading this morning.