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updated 11/18/2011 10:54:55 AM ET 2011-11-18T15:54:55

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.

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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."

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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 continue to cover Avastin," Don McLeod, spokesman for the Centers for Medicare and Medicaid, or CMS, said on Friday.

"CMS 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."

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The statement from the U.S. healthcare program could mitigate concerns that patients using the drug would lose insurance coverage should the FDA revoke approval for its use in breast cancer.

"We are disappointed with this outcome," said Charlotte Arnold, a spokeswoman for Genentech, a unit of Roche. "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."

She said Roche will pursue a new Phase III study of Avastin in combination with the chemotherapy drug paclitaxel in previously untreated metastatic breast cancer.

The FDA's decision could prompt a review of industry guidelines from groups like the National Comprehensive Cancer Network, which represents leading cancer treatment centers.

NCCN has so far not strayed from its earlier guideline, approving use of Avastin with paclitaxel for some patients.

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.

The Associated Press and Reuters contributed to this report


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