FDA revokes approval of breast cancer drug

FDA.Protest.June2011.jpgIt’s finally official: the US Food and Drug Administration (FDA) has withdrawn its approval of the drug Avastin (bevacizumab) to treat advanced breast cancer. Avastin retains its approval for some other colon, kidney, and brain cancers.

The decision comes as no surprise to those watching the saga unfold since last year. In December, an advisory board voted 12-1 to recommend withdrawal of the breast cancer indication because Avastin failed to significantly improve survival, yet posed a risk of serious side effects. Genentech, which developed the drug, protested the decision in an unusual hearing held this summer. (See FDA hearing on Avastin draws protestors’.) The advisory committee stuck to its earlier decision. (See ‘Committee votes to withdraw approval for breast cancer drug’.)

Now the FDA has, as it often does, sided with its advisory committee. The decision to pull the breast cancer indication for Avastin will come as a blow to the patient advocates who protested at the FDA hearing last June (pictured). Indeed, many health care workers still believe the drug could help breast cancer patients despite evidence to the contrary. A survey of 564 health care workers published in the journal Cancer in October showed that 46.5% would still use the drug to treat some advanced breast cancers.

Photo courtesy Abigail Alliance for Better Access to Developmental Drugs

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