Drug regulators withdrew their approval of Roche’s Avastin for breast cancer by remarking the drug was not effective enough for justifying its risks even if patients believe it has helped them live longer.
U.S. Food and Drug Administration Commissioner Margaret Hamburg said reversing course on a drug that was approved for the disease in 2008 that 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.”
While doctors still have discretion in using Avastin for breast cancer off-label, the FDA move may lead health insurers to drop coverage of a medicine that costs $88,000 a year.
“The bottom line is that they are throwing out the baby with the bathwater,” said Dr. Elisa Port, co-director of the Dubin Breast Center of Mount Sinai Hospital in New York. “There absolutely may be subsets of carefully chosen breast cancer patients who benefit from Avastin.”