In a stunning rebuke to the former director of the Food and Drug Administration (FDA), an advisory panel has recommended removing the approval of the drug Avastin (bevacizumab) for breast cancer. The vote was 12 to 1 to revoke the previous approval. The panel concluded that the drug was not in fact helping breast cancer patients. In 2008 I joined with Breast Cancer Action (BCA), based in San Francisco, in opposing this approval. But at the time there was no stopping Avastin's manufacturer, Genentech, and the drug has gone on to become the world's best-selling cancer drug, with worldwide sales of around $6 billion.

According to an informative article in the New York Times, "The product has at times been hailed as a near miracle" (Pollack 2010). Supposedly, the current data on advanced breast cancer corrects the initial impression of benefit that led to its 2008 approval in advanced BC. I for one was never impressed by the data in BC and argued forcefully against approval for that indication.

"I'm really not seeing that this has a benefit for patients," said Natalie Compagni Portis, the patient representative on the committee. "Hope is very important, but to offer hope that isn't substantiated I don't think is responsible." Since, no matter how FDA rules, Avastin will stay on the market for colon, lung, kidney and brain cancers, it will continue to be available for breast cancer as well. However, removing this indication for breast cancer will probably mean that insurance will no longer pay for the treatment and BC patients would not be eligible for the price reduction to $57,000 offered by the company for patients with incomes below $100,000.

TO BE CONCLUDED NEXT WEEK WITH REFERENCES.

NOTE: Also be sure to read my previous Current Topic report, "Avastin, Your Money or Your Life." To order a copy please click here.

--Ralph W. Moss, Ph.D.

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