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Bayer/Onyx Drug Stivarga Receives Approval for Treatment of Rare Tumor

Update Date: Feb 26, 2013 03:42 AM EST
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Bayer's Stivarga (regorafenib) has now been approved for use in people suffering from advanced gastrointestinal stromal tumors (GIST), the Food and Drug Administration announced Monday. The agency said that Stivarga can be used to treat the cancer when the tumor can't be surgically removed or treated with other FDA-approved drugs.

The drug was approved for use by the FDA in September 2012 for treating colorectal cancer.

Gastrointestinal stromal tumor is a disease where abnormal cells begin to develop in the tissues of the gastrointestinal tract, according to the National Cancer Institute. This tumor makes roughly 1 percent of all gasteointestinal tumors and an estimated 3000 to 6000 people are diagnosed with this tumor each year.

FDA said that the new drug Stivarga is multi-kinase inhibitor and checks cancer growth by inhibiting various enzymes that promote tumor growth. The approval is mainly for people with GIST who can't undergo surgery and have stopped responding to drugs like Gleevec (imatinib) which is made by Novartis, and Sutent (sunitinib) made by Pfizer.

The safety of the drug was tested on 199 patients with GIST who weren't responding to other treatments. The study participants were either given a dose of Stivarga or a dummy drug.

"Stivarga is the third drug approved by the FDA to treat gastrointestinal stromal tumors. It provides an important new treatment option for patients with GIST in which other approved drugs are no longer effective," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

Study results showed that people on Stivarga had slower tumor progression (3.9 months on an average) than people on placebo. The most common side-effects were weakness, diarrhea, loss of appetite, high blood pressure, mouth sores, etc. Some serious side-effects were liver damage, extremely high blood pressure and heart attack.

The drug will cost around $9,350 per 28-day cycle, Shannon Campbell, vice president and general manager of Bayer's oncology business, said in a telephone interview with Reuters Health.

The drug is jointly promoted by Bayer and Onyx in the U.S.         

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