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FDA panel recommends withdrawing Avastin indication for breast cancer treatment


An FDA advisory panel recommended in late June that Avastin should not be used to treat breast cancer.

An FDA advisory panel recommended in late June that Avastin should not be used to treat breast cancer.

FDA’s Oncology Drug Panel voted unanimously that Avastin’s approval for breast cancer treatment be withdrawn. During the hearings, patient groups such as the Abigail Alliance fought for continued use of Avastin in breast cancer treatment.

Avastin was first approved in 2004 to treat advanced colon cancer and has since been approved for lung, kidney, and brain cancers. FDA proposed withdrawing Avastin’s approval to treat metastatic breast cancer in late 2010, saying that there was not enough evidence to show that the drug is safe and effective for breast cancer treatment.

Avastin’s manufacturer, Genentech, a subsidiary of Roche, lobbied FDA and Congress for a second hearing on the issue in late December. Avastin generates more than $6 billion a year for the company, according to news reports.

The advisory panel recommendation does not signify a final FDA decision. FDA’s public comment period on Avastin withdrawal remains open until July 28, 2011. Sometime after that, FDA Commissioner Margaret Hamburg will make a final decision on use of Avastin use for breast cancer.

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