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Avastin Fails to Win Over FDA Panel as Breast Cancer Treatment

Jun 30, 2011 | Parker Waichman LLP


For the second time in about a year, the Food & Drug Administration (FDA) oncology panel has voted to reject Avastin as a breast cancer treatment.   The 6-0 vote was taken yesterday, at the conclusion of a contentious and emotional hearing in which the maker of Avastin tried to persuade the panel that the drug should keep its breast cancer indication.

The FDA initially announced in December that it was moving to revoke Avastin's breast cancer approval.  In doing so, the FDA said there was little evidence that Avastin improves survival time for breast cancer patients, and cited its association with serious complications, including perforations of the intestines and other parts of the body, bleeding, and cardiovascular problems.

Despite emotional appeals from breast cancer patients and their advocates, the FDA panel did not change the position it held nearly a year ago, when it first voted that Avastin should no longer be approved for breast cancer patients. 

Prior to the vote, Mikkael Sekeres, associate professor of medicine at the Cleveland Clinic Taussig Cancer Institute and one of the panel members, said that studies submitted by Genentech, a division of Roche Holdings, provided "nothing we can hang our hat on in these studies that would make me feel comfortable continuing to expose a lot of patients to risk without a clear benefit."

After the panel voted, those in the audience loudly voiced their disapproval.

"This was a kangaroo court," said Steven Walker, co-founder of the group Abigail Alliance, according to the Associated Press. "There wasn't one dissenting thought up there, let alone one dissenting vote."

FDA Commissioner Margaret Hamburg still must make the final decision on the breast cancer indication.  Until she does, Avastin will continue to hold an approval for breast cancer.   Hamburg is not bound by the panel's vote, and could choose to allow the indication to stand.

Regardless of her decision, Avastin will still hold approvals for several other cancers, including metastatic colon cancer, non-small cell lung cancer, kidney cancer and glioblastoma multiforme, an incurable brain cancer.  If Avastin ultimately loses the breast cancer indication, doctors could still prescribe the drug-off label to treat such patients. However, many insurance companies will likely refuse to cover the high cost of the drug - $100,000 per year when all costs are figured - for that purpose.




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