FDA panel deals blow to Avastin hopes

Avastin got the big thumbs-down from an FDA advisory panel yesterday. The Genentech drug, approved for use against colon and lung cancer, was up for consideration as a breast-cancer therapy, but expert panelists weren't impressed with the data.

One key study showed that Avastin delayed tumor growth, but didn't increase survival time, The panel decided those results didn't warrant approval, considering that the drug also appeared to cause a small number of heart attacks, blood clots, and deaths. The group voted 5-to-4 against approval. Of course the agency could go against its experts' recommendation, but such a move is rare.

Ironically, Avastin won approval from European regulators as a breast-cancer treatment, based on the very same data presented to the FDA. Roche, Genentech's majority owner, markets the drug on that continent. In its statement about the vote, Genentech said it still hopes to persuade the FDA that Avastin is effective for breast cancer.

- see Genentech's release
- check out the article from the Los Angeles Times

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