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UPDATE: The Avastin Argument


UPDATE: An FDA advisory panel has once again voted to remove the breast cancer indication from Avastin's label, unconvinced by evidence presented by Roche that claims certain breast cancer patients respond very well to the drug. Despite FDA's decision, Roche subsidiary Genentech says it will move forward with plans to study a certain group of breast cancer patients with high levels of VEGF-A that the company calls "super responders," as they respond to Avastin very well.

Cancer Minute's sister publication Pharmacogenomics Reporter has more on the outcome here and here.

Drug maker Roche and FDA officials are going head-to-head in Washington, DC this week, with FDA scientists fighting to uphold their decision to revoke approval for the use of cancer drug Avastin to treat breast cancer, and Roche fighting to get the drug re-approved, reports The Wall Street Journal's Alicia Mundy. FDA officials say Avastin — which is approved to treat several different cancers — shouldn't be used in breast cancer because it puts the patient at risk without conferring much benefit, Mundy says. But Roche, whose Genentech unit created the drug, opposed the decision. Roche won accelerated approval for the use of Avastin in breast cancer in 2008, but after several studies suggested it created too much risk of adverse side effects with minimal effect on the cancer, an FDA advisory panel voted 12 to 1 in favor of revoking the approval. Now, FDA scientists from the Center for Drug Evaluation and Research and representatives from Roche will argue their cases in front of an FDA official with no ties to the case and an independent panel of experts, Mundy says. FDA accuses Roche of making this a political issue that should be decided by scientists, and Roche says FDA understated Avastin's ability to delay tumor regrowth, she adds. Genentech says it wants to keep the breast cancer label while it does more studies to back up its claims, but this could take several years. But some fear the consequences for FDA itself if the revocation is reversed. "Some doctors familiar with the FDA's internal debate warn that if the agency's drug division loses the trial, it might ease away from accelerated approvals of future cancer drugs out of fear that they will be too hard to revoke," Mundy says.

The Scan

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