Stivarga Approved for Advanced Colorectal Cancer
THURSDAY, Sept. 27 -- 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.
The U.S. National Cancer Institute has more about colon and rectal cancer.
Posted: September 2012