FDA Approves Stivarga for Treating Advanced Gastrointestinal Stromal Tumors

The Food and Drug Administration Feb. 25 expanded the approved use of 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 was approved in September 2012 to treat colorectal cancer (10 PLIR 1293, 10/5/12). It is marketed by Wayne, N.J.-based Bayer HealthCare Pharmaceuticals. Bayer’s parent company is based in Germany.

GIST is a tumor in which cancerous cells form in the tissues of the gastrointestinal tract, part of the body’s digestive system, the agency said. Stivarga, a multikinase inhibitor, ...