FILE - This May 25, 2004 file photo shows aspirin tablets. Aspirin, one of the world's oldest and cheapest drugs, has shown remarkable promise in treating colon cancer in people with certain genetic mutations that often play a role in the disease. The study appears in the Thursday, Oct. 25, 2012 New England Journal of Medicine. (AP Photo/Houston Chronicle, Dave Einsel) (AP)
The Food and Drug Administration has expanded approval of a Bayer cancer pill that treat tumors of the intestinal tract that don't respond to other treatments.
The regulators announced Monday that the drug Stivarga is approved to treat gastrointestinal stromal tumors that cannot be surgically removed and no longer respond to other FDA-approved drugs.
The FDA previously approved Stivarga to treat colorectal cancer. It works by blocking several enzymes that promote cancer growth.
The FDA approved the drug for the new use based on a study of nearly 200 patients who were randomly assigned to take Stivarga or a placebo pill.
Patients taking the drug experienced a nearly four month delay in the growth of their tumors compared to taking placebo.
The most common side effects of Stivarga in clinical trials included liver damage, severe bleeding, blistering and peeling of skin, high blood pressure, heart attacks and perforations.
Other drugs approved to treat intestinal tumors include Gleevec and Sutent, both made by Pfizer Inc.
Based on reporting by the Associated Press.
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