FDA panel: Avastin ineffective for breast cancer


For the second time, a federal expert panel has decided that the drug Avastin the top-selling cancer drug in the world doesn't help women with advanced breast cancer and may even harm them.

A Food and Drug Administration advisory panel voted 6-0 Wednesday to withdraw Avastin's approval for treatment of breast cancer. The drug remains on the market for now, however, and agency Commissioner Margaret Hamburg will make the final call.

Avastin, which can cost more than $100,000 a year, is one of the most expensive cancer therapies in the world, but also one of the most lucrative, with $6 billion in annual sales.

The FDA granted Avastin "accelerated approval" in 2008, against the advice of advisers, after preliminary studies showed that it helped slow tumor growth. The program aims to speed potentially life-saving drugs to critically ill patients. The FDA can revoke approval if later tests fail to confirm the drugs are safe and effective.

In Avastin's case, follow-up studies found that breast cancer patients who took it didn't live any longer than other patients and suffered more serious side effects, such as blood clots and high blood pressure. In December, the FDA said it would revoke approval.

The decision has been controversial. While the majority of women don't benefit from Avastin, some patients insist it has helped them and are desperate to continue taking it. The drug's maker, Genentech, which is owned by Roche, appealed, and in an unprecedented move, the FDA granted a second hearing.

Some breast cancer advocates applauded Wednesday's decision. Fran Visco, president of the National Breast Cancer Coalition, says the panel voted for "scientific evidence in the face of intense public and media pressure."

In a statement, Visco said women "deserve drugs that save lives and significantly improve quality of life. We need to focus on finding therapies that will make a real difference."

Avastin will still be available because it's also approved to treat other cancers. But insurers may decide not to pay for Avastin in breast cancer.

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