FDA Panel Rejects Avastin for Breast Cancer a Second Time

A panel of Food & Drug Administration (FDA) advisors has again rejected <"http://www.yourlawyer.com/topics/overview/Avastin-Side-Effects-Lawyers-Lawsuit-Attorney">Avastin as a treatment for breast cancer. In a 6-0 vote, the FDA oncology panel ruled for a second time that Avastin is not clinically beneficial, effective or safe for treating breast cancer.

The FDA announced in December that it was beginning the process of revoking Avastin’s breast cancer approval, after determining that Avastin does not prolong overall survival in breast cancer patients. The agency also said Avastin’s benefits in treating breast cancer did not outweigh its risk of complications, including bleeding and hemorrhage; the development of perforations in the intestines and other areas of the body; and heart attack or heart failure.

Yesterday’s vote came at the end of a two day appeal hearing – the first of its kind at the FDA – in which Genentech, a division of Roche Holdings tried to convince the agency to reverse its earlier decision. Roche had argued that Avastin should remain available to patients with aggressive breast cancer while it conducts studies to determine which are most likely to benefit from the drug.

According to a report from the Associated Press, the two-day hearing was at times contentious and emotional, with Avastin patients and their families speaking out against the FDA’s decision.

“Make no mistake, this hearing is a death trial not of Avastin but of these women who rely on Avastin to say alive,” testified Terry Kalley, whose wife takes Avastin for breast cancer. “You are each personally responsible for the consequences of your own vote.”

But in the end, the panel was not swayed by such arguments.

“No matter what way we look at it, there’s 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,” said Mikkael Sekeres, associate professor of medicine at the Cleveland Clinic Taussig Cancer Institute and one of the panel members.

“I think we all wanted Avastin to succeed but the reality is that these studies did not bear out that hope,” said Natalie Compagni-Portis, the only patient representative on the FDA panel.

After the vote was taken, the audience protested by shouting its disapproval, the Associated Press said.

“What do you want us to take!? We have nothing else!” shouted Christi Turnage, of Madison, Mississippi. Turnage told the Associated Press that her breast cancer has been undetectable during the two years she has been treated with Avastin.

The final decision on whether or not the breast cancer indication for Avastin will be revoked will be made by FDA Commissioner Margaret Hamburg. Even if she concurs with the panel’s vote, doctors could still prescribe the drug off-label to treat breast cancer 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.

Avastin is also approved to treat a variety of other cancers, including metastatic colon cancer, non-small cell lung cancer, kidney cancer and glioblastoma multiforme, an incurable brain cancer. Those indications will not be impacted by the FDA’s final breast cancer ruling.

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