06/28/2011 03:07 pm ET Updated Aug 28, 2011

UPDATE: FDA Votes Down Avastin For Breast Cancer


A Food and Drug Administration panel voted today to revoke Avastin's approval for treatment of breast cancer.

The panel voted 6-0 to remove the breast cancer indication from the drug, the Wall Street Journal reported.

Avastin, the best-selling cancer drug in the world, had been the subject of FDA meetings over the last two days.

The drug's benefits weren't deemed to outweigh its dangerous side effects, USA Today reported.

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What will be the fate of Avastin?

That's the question the Food and Drug Administration will answer after two days of meetings. The government agency will decide whether or not to eliminate approval of the drug as a treatment for breast cancer.

Breast cancer patients testified in support of the drug today, appealing the FDA not to act on its December proposal to remove the drug's breast cancer indication. Avastin is manufactured by the Swiss drugmaker Roche, and is approved for metastasized breast cancer (advanced breast cancer that has already spread to other parts of the body).

"I am alive today due to Avastin," breast-cancer survivor Patricia Howard said at the hearing, Reuters reported.

This isn't the first time there's been an FDA panel vote to decide whether Avastin should be used to treat breast cancer. Last year, a panel voted to withdraw approval for the drug to treat advanced breast cancer because studies showed it didn't help patients live longer, CNN reported.

There were also side effects of the drug, including internal bleeding, holes in the stomach and high blood pressure, that prompted the Center for Drug Evaluation and Research (part of the FDA) to propose removing Avastin's breast cancer indication, CNN said.

But Avastin-maker Genentech, a unit of Roche, appealed that recommendation, and will make its case for the breast cancer indication at this week's meetings, Bloomberg reported.

Avastin was initially granted approval to treat breast cancer in 2008 because it demonstrated in studies its ability to slow advanced breast cancer tumor growth, when combined with chemotherapy, for more than five months.

But follow-up studies showed that the benefit was actually more like one to three months, and breast cancer patients were not living any longer than if they didn't take the drug. Genentech said even those few months are meaningful to advanced cancer patients, however.

Despite the FDA's decision this week, the drug is still approved to treat brain, kidney, lung and colon cancers. Technically the drug could still be used to treat breast cancer even if the FDA rules against it, but insurers would likely no longer cover it.