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Pull Approval for Breast Cancer Drug, Experts Tell FDA Pull Approval for Breast Cancer Drug, Experts Tell FDA

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HEALTH CARE

Pull Approval for Breast Cancer Drug, Experts Tell FDA

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Roche subsidiary Genentech's drug Avastin does not help breast cancer patients, an FDA panel says.(Justin Sullivan/Getty Images)

The cancer drug Avastin does not help breast cancer patients and it should not be approved to treat them, experts advising the Food and Drug Administration said on Wednesday.

Despite emotional appeals from breast cancer patients who fear they may lose their one shot at survival, and pressure from drug giant Roche, the six-member panel voted unanimously that Avastin should not be approved to treat breast cancer.

 

FDA Commissioner Margaret Hamburg will make the final decision, but even the patient representative on the panel, Natalie Compagni-Portis, agreed the evidence was clear. “I think we all wanted Avastin to succeed, but the reality is that these studies did not bear out that hope,” she said, according to AP.

Avastin, which generates $6 billion a year in sales for Roche, is approved for a range of other cancers, including colon cancer and some brain tumors. An FDA ruling does not affect what doctors may do -- doctors may prescribe any approved drug for any reason they see fit, a practice called off-label prescribing.

The docket will remain open for public comment until that date until July 28, the FDA said.

 

"The Commissioner’s decision related to breast cancer will not affect Avastin’s approved indications for use in colon, lung, kidney, and brain cancers. That is, regardless of the final decision on metastatic breast cancer approval, Avastin will remain on the market," the FDA added in a statement.

What the FDA's ruling can affect is whether insurers, including Medicare, will pay for the drug in treating breast cancer. This is what worries advocates and Roche, as Avastin can cost up to $88,000 a year and the loss of the breast cancer market could cost Roche up to $1 billion a year, analysts have projected.

The FDA's approval of Avastin in the first place was an unusual move meant to speed the drug to patients. The agency's condition was that Roche do post-market studies to show it was worthwhile. Those studies showed the drug could delay the cancer's spread, but in the end it did not help patients live longer than standard treatments.

And it can have serious side effects, such as holes in the stomach.

 

"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.

“This was a kangaroo court,” said Steven Walker of the Abigail Alliance, which advocates for patient access to experimental medicine. “There wasn’t one dissenting thought up there, let alone one dissenting vote.”

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