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FDA Declines Avastin Breast Cancer Drug Approval

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11/19/2011 03:30 PM ET

FDA Avastin - The FDA says the drug Avastin should not be used to treat breast cancer that has spread to other organs because it doesn’t help patients enough to justify its risky side effects.

The decision comes five months after a Food and Drug Administration advisory committee recommended that the federal agency withdraw its approval of the drug for breast cancer patients. Clinical trial results have for years fueled doubts about its value for treating breast cancer.

Still, FDA Commissioner Margaret Hamburg said the choice was difficult because so many women and their doctors have put their faith in the drug and lobbied hard on its behalf.

“I did not come to this decision lightly,” she said. “Sometimes, despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing.”

The drug will remain on the market for treating other types of cancer where the benefits clearly outweigh the risks, such as lung, kidney and colon cancer, Hamburg said. As long as it is available, doctors will have the flexibility to prescribe it for breast cancer patients as an off-label use, although insurance companies might not be willing to pay for it.

Medicare, however, will continue to pay for Avastin, at least for now, officials said.

Avastin, among the top-selling cancer therapies and drugs, is a biological antibody designed to interfere with the blood supply that feeds a tumor and helps it grow and spread. But it can cause harsh side effects, including heart attacks and strokes. It’s also among the most expensive cancer therapies, costing upward of $88,000 a year.

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