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A vial of Genentech's Avastin. (Genentech)

Expert Panel Tells FDA To Pull Approval Of Avastin For Breast Cancer

Jun 29, 2011

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In the end, Genentech failed to persuade a single member of the Food and Drug Administration's panel of cancer experts that its blockbuster drug Avastin should keep the agency's seal of approval for treating advanced breast cancer.

Wednesday's vote echoes the panel's 12-1 decision last summer to withdraw the $88,000-a-year drug's approval for breast cancer.

After that, the FDA announced last year it intended to withdraw the conditional approval it granted Avastin in 2008 because follow-up studies didn't show the same benefit — in terms of reducing cancer regrowth — as an initial study. Genentech, the drug's maker, had appealed the FDA's decision.

The company, which sells about $1 billion worth of Avastin worldwide to treat breast cancer, strenuously challenged the FDA's interpretation of the evidence, and the legal basis for withdrawing approval.

Genentech's team also argued that FDA staffers had misled them about the acceptability of the company's follow-up studies.

Perhaps most potently, women testified that Avastin had extended their lives. And pro-Avastin protesters in breast cancer pink picketed the FDA's Maryland headquarters.

But at the conclusion of a two-day meeting, the advisory panel said the evidence just wasn't there to support a meaningful benefit, while Avastin users suffer serious side effects not seen with alternative treatments.

Referring to women and doctors who say Avastin works for some, panel member Dr. Ralph Freedman of the University of Texas said the FDA "has to look at protecting a larger number of patients. So sometimes they have to make a decision that doesn't favor individual patients."

After the vote Genentech expressed hope that FDA Commissioner Margaret Hamburg will not go along with her staff and outside experts in removing Avastin's approval for breast cancer.

But if she does, as expected, it's not clear what impact it will have on patients. Some groups that recommend "off-label" or unapproved drug use have indicated they'll keep Avastin on their list for breast cancer.

FDA officials say if the vote had gone the other way the agency might have trouble in the future withdrawing conditional approvals when the evidence to support them doesn't hold up.

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