The blockbuster drug Avastin should no longer be used in advanced breast cancer patients because there's no proof that it extends their lives or even provides enough temporary benefit to outweigh its dangerous side effects, the government declared Friday.
The ruling by the Food and Drug Administration was long expected, but it was certain to disappoint women who say they've run out of other options as their breast cancer spread through their bodies. Impassioned patients had lobbied furiously to preserve Avastin as a last shot.
But repeated studies found the drug had only a small effect on tumor growth. The research didn't show evidence that patients lived any longer or had a better quality of life than if they had taken standard chemotherapy. The FDA concluded that the drug presented an array of risks, including severe high blood pressure, massive bleeding, heart attack or heart failure, along with perforations in the stomach and intestines.
"I did not come to this decision lightly," said the FDA commissioner, Dr. Margaret Hamburg. But, she said, "Sometimes despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing."
Avastin is the world's best-selling cancer drug, and also is used to treat certain forms of colon, lung, kidney and brain cancers. So even though FDA formally revoked its approval of the drug to treat breast cancer, doctors still could prescribe it — but insurers may not pay for it. Including infusion fees, a year's treatment with Avastin can cost $100,000.
Some insurers already had quit covering the drug's use in breast cancer after FDA's advisers twice — once last year and once this summer — urged revoking the approval.
But Medicare said Friday that it will keep paying for now. In a statement, the agency said it "will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies."
Hamburg said any woman wishing to remain on Avastin should have an in-depth discussion with her doctor about the risks and what the research into the drug showed.