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Panel tells FDA to withdraw approval of Avastin for breast cancer

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A Food and Drug Administration advisory committee Tuesday recommended that the agency withdraw approval of the blockbuster cancer drug Avastin for treating breast cancer. The decision would not affect the manufacturer’s ability to market the drug for treating colon, lung and other cancers.

Avastin contributes annual sales of about $6 billion to its manufacturer, Roche, with about a sixth of that from sales for breast cancer.

When the FDA initially approved the drug for breast cancer in 2008, the agency required Roche to perform additional studies of its efficacy. Those studies, the panel concluded in a 12-1 vote, showed that the drug provided no benefit in the condition.

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The FDA is expected to make a final decision by Sept. 17. It is not required to follow the advice of the panel but generally does.

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