(HealthDay)—Stivarga (regorafenib) has been approved by the U.S. Food and Drug Administration to treat colorectal cancer that has spread despite prior treatment.
The drug belongs to a class called multi-kinase inhibitors, which are designed to block enzymes that promote cancer growth, the FDA said in a news release.
Stivarga's safety and effectiveness were evaluated in a clinical study of 760 people who had been treated previously for advanced colon cancer. People who took Stivarga lived an average of 6.4 months, compared with people given a placebo who lived an average of five months, the FDA said.
The most common side effects of the new drug included: weakness, fatigue, loss of appetite, diarrhea, mouth sores, weight loss, infection, high blood pressure and changes to the voice.
Stivarga was approved with a boxed label warning of the possibility of severe and fatal liver problems, the FDA said.
The drug is marketed by Bayer HealthCare Pharmaceuticals, based in Wayne, N.J.
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Aug 04, 2012
