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FDA approves Stivarga for advanced gastrointestinal stromal tumors

The U.S. FDA expanded the approved use of Stivarga to treat patients with advanced gastrointestinal stromal tumors that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease. With this new approval, Stivarga is intended to be used in patients whose GIST cancer cannot be removed by surgery or has spread to other parts of the body and is no longer responding to Gleevec and Sutent, two other FDA-approved drugs to treat GIST. Stivarga was reviewed under the FDA’s priority review program. The drug was also granted orphan product designation. Stivarga was approved in September 2012 to treat colorectal cancer. It is marketed by Bayer HealthCare Pharmaceuticals (BAYRY). Gleevec and Sutent are marketed by Pfizer (PFE).