WASHINGTON - US drug regulators withdrew their approval of Roche's Avastin for breast cancer, saying the drug was not effective enough to justify its risks even if patients believe it has helped them live longer.
Reversing course on a drug that was approved for the disease in 2008, US Food and Drug Administration Commissioner Margaret Hamburg said subsequent research did not confirm hopes that Avastin would help patients with advanced breast cancer live longer or improve quality of life.
The drug will remain on the market for other uses, such as treating types of colon, lung, kidney and brain cancer.
"This was a difficult decision," Hamburg said. "With so much at stake, patients and their doctors count on the FDA to ensure the drugs they use have been shown to be safe and effective for their intended use. Sometimes, the results of rigorous testing can be disappointing."