On Monday, the FDA expanded approval of a Bayer cancer drug to treat tumors of the intestinal tract that don't respond to other treatments.
The drug, Stivargo, was approved by regulators to treat gastrointestinal stromal tumors that can’t be surgically removed and don’t respond to other FDA-approved drugs.
Previously, Stivarga was approved by the FDA to treat colorectal cancer, which works by blocking several enzymes that promote cancer growth.
The agency then approved the drug for treating intestinal tract tumors after a study showed it delayed the growth of the tumors.
For the study, 200 patients were randomly assigned to take Stivarga or a placebo pill. Those taking Stivarga had the growth of their tumors delayed by nearly four months compared to the placebo group.
There were serious side effects associated with Stivargo in clinical trials, which include liver damage, severe bleeding, blistering and peeling of skin, high blood pressure, heart attacks and perforations.
There are also other drugs approved to treat intestinal tumors, such as Gleevec, a Novartis drug, and Sutent, which is made by Pfizer.
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