FDA Revokes Approval of Avastin for Breast Cancer

WASHINGTON (AP) -- The blockbuster drug Avastin should no longer be used in advanced breast cancer patients because there's no proof that it extends their lives and it presents 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.

"This was a difficult decision," said FDA Commissioner Margaret Hamburg. But, she added that "it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks."

Those risks include severe high blood pressure, massive bleeding, heart attack or heart failure, and perforations in parts of the body such as the stomach and intestines, she said.

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 last summer, urged revoking the approval.

But Medicare said Friday that it will keep paying for now.

Medicare "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," said spokesman Don McLeod.

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.

But when Avastin manufacturer Genentech did those studies, the data showed only a small effect on patients' tumor growth, not that they were living longer or had a better quality of life and not enough benefit to outweigh such severe side effects, FDA concluded.

Genentech, part of Swiss drugmaker Roche Group, had argued that Avastin should remain available while it conducts more research to see if certain groups of patients might benefit from the drug.

Hamburg encouraged Genentech do those studies

Roche and Genentech did not immediately comment Friday.

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