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FDA approves Stivarga for advanced gastrointestinal stromal tumors

At 25th of Feb. 2013 the U.S. Food and Drug Administration expanded the approved use of Bayer Pharmaceutical's drug 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.

Stivarga, a multi-kinase inhibitor, blocks several enzymes that promote cancer growth. 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 (metastatic) and is no longer responding to Gleevec (imatinib) and Sutent (sunitinib), two other approved drugs to treat GIST. It provides an important new treatment option for patients with GIST in which other approved drugs are no longer effective.”

Stivarga was reviewed under the FDA’s priority review program, which provides an expedited six-month review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. The drug was also granted orphan product designation because it is intended to treat a rare disease.

The safety and effectiveness of Stivarga for this use were evaluated in a multinational clinical study of 199 patients with GIST that could not be surgically removed and progressed after treatment with Gleevec or Sutent. Patients were randomly assigned to receive either Stivarga or a placebo.

Patients in the study took Stivarga or placebo until either the cancer progressed or the side effects became unacceptable. Results showed patients who took Stivarga had a delay in tumor growth (progression-free survival) that was, on average, 3.9 months later than patients who were given placebo. Patients who received the placebo were given the opportunity to switch to Stivarga when their cancer progressed.

Among the possible side effects noted in the trial were liver problems, hypertension, hand-foot syndrome, fatigue and diarrhea.

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