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FDA OKs Expanded Use Of Bayer/Onyx Drug For Rare Gastrointestinal Tumor

 February 25, 2013 02:51 PM
 


(By Balachander) The U.S. Food and Drug Administration (FDA) has approved the expanded use of Bayer AG's drug Stivarga to treat a rare type of gastrointestinal tract cancer.

Stivarga, which was approved in September 2012 to treat colorectal cancer, is the third drug cleared by the U.S. health regulators to treat gastrointestinal stromal tumors (GIST).

Germany-based Bayer and South San Francisco, California-based Onyx Pharmaceuticals Inc. (NASDAQ: ONXX) co-promote Stivarga - known as regorafenib - in the United States.

The FDA on Monday approved Stivarga for patients whose GIST cannot be surgically removed and no longer respond to other FDA-approved treatments Novartis' (NVS) Gleevec and Pfizer's (PFE) Sutent.

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GIST is a tumor in which cancerous cells form in the tissues of the gastrointestinal tract, part of the body's digestive system. According to the National Cancer Institute, an estimated 3,300 to 6,000 new cases of GIST occur yearly in the United States, most often in older adults.

According to the FDA, clincial study results showed patients taking Stivarga had a delay in tumor growth that was, on average, 3.9 months later than patients who were given a placebo.

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The most common side effects reported in patients treated with Stivarga were weight loss, stomach pain, rash, fever, hand-foot syndrome, diarrhea, loss of appetite, high blood pressure and nausea.

Onyx shares inched 0.13 percent higher to trade at $78.40 at 2.38 pm ET on Monday.

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