FDA revokes approval of Avastin for breast cancer

WASHINGTON — 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.

Avastin manufacturer Genentech, part of Swiss drugmaker Roche Group, had argued that the drug should remain available while it conducted more research to see if certain subsets of breast cancer patients might benefit, perhaps people whose tumors contain certain genetic characteristics. After all, some doctors had argued that they do see a few patients who seem to do better with Avastin than without it.

Hamburg said she considered that argument, but that scientifically there are no clues yet to identify such women. She urged Genentech to do that research, saying FDA "absolutely" would reconsider if the company could find the right evidence."

"We're eager to work with the company, and we hope that the science will advance and that we will be able to offer patients with metastatic breast cancer better, safer, more effective treatments for this devastating disease," Hamburg said.

Genentech pledged to begin such research.

"We are disappointed with the outcome. We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States," said company chief medical officer Dr. Hal Barron.


One patient advocacy group called the decision a mistake.

"Any one life is significant. In this case we're talking about several thousand lives a year," said Frank Burroughs of the Abigail Alliance, which advocates for access to experimental medicine.

In 2008, the FDA allowed Avastin to be marketed as a treatment for breast cancer that has spread, or metastasized, to other parts of the body and is generally considered incurable. The approval came under a special program that allows patients access to promising treatments while their makers finish the studies needed for final proof that they really work as promised. That approval is revoked if the research doesn't pan out, something that happens only very rarely.


Associated Press Writer Marley Seaman in New York contributed to this report.

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