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Avastin Should No Longer Be Used to Treat Breast Cancer, FDA Says

Avastin Should No Longer Be Used to Treat Breast Cancer, FDA Says

December 16, 2010, 02:12 pm

The U.S. Food and Drug Administration (FDA) has announced that the popular cancer drug known as Avastin should no longer be used to treat breast cancer.

The move comes after an extended review of Avastin's effects in breast cancer patients. In July, an independent advisory committee voted 12 to 1 to remove the breast cancer indication from Avastin's label. However, in September, the FDA announced that it would take several more months to review the drug before announcing a decision.

The FDA maintains it has come to the conclusion to remove Avastin's breast cancer indication after reviewing the results of four clinical trials. Trial data showed the drug did not prolong overall survival time or slow disease progression enough in women with breast cancer to outweigh its serious risks, which include side effects such as high blood pressure, bleeding, heart attack and the development of perforations in the body.

Avastin was granted an indication for breast cancer in February 2008 under the FDA's accelerated approval program. The move came after the medication showed the ability to delay cancer growth by 5.5 months. Avastin's breast cancer indication required the medication be used in conjunction with another chemotherapy drug known as paclitaxel.

According to an FDA press release, "Removing the breast cancer indication from the Avastin label will be a process. This is the first step."

Avastin is used to treat a number of other cancers including colon, kidney, brain and lung cancer. The medication is still approved to treat these conditions and is not being removed from the market. The FDA has advised physicians currently treating breast cancer patients with Avastin to use their own judgment in deciding whether to continue using the drug or to seek other alternatives.

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