Avastin's breast cancer approval revoked by FDA

CBS

(CBS/AP) Avastin for breast cancer is out. The FDA says the drug should no longer be used for breast cancer because there's no proof it extends patients' lives - and it causes dangerous side effects.

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Friday's ruling was long expected. An FDA advisory panel in June unanimously voted to revoke Avastin's approval for treating breast cancer over those concerns, CBS News reported.

"I think we all wanted Avastin to succeed but the reality is that these studies did not bear out that hope," Natalie Compagni-Portis, a patient representative on the FDA's panel, said at the time.

But the ruling is sure to disappoint women who say they've run out of other options.

FDA Commissioner Dr. Margaret Hamburg called the decision difficult but said patients must have confidence that drugs sold for their condition are effective.

The FDA granted Avastin accelerated approval in 2008 based on one study in which it slowed breast cancer tumor growth for more than five months when combined with chemotherapy. But in follow-up studies the delay shrunk to less than three months. Across all studies, patients taking Avastin did not live any longer and suffered side effects like infection, high blood pressure, and blood clots.

Avastin won't stop selling, as it's also used to treat colon cancer and certain other tumors. But the FDA ruling is expected to influence insurance coverage. Medicare says it will continue to cover Avastin while it evaluates whether a change is needed.

Back in June when the FDA's panel first made its recommendation, doctors' opinion was split.

"I think the FDA is doing the right thing since the drug has some serious complications," said Dr. Stephanie Bernik of Lenox Hill Hospital in New York. "However, there are definitely patients who are benefiting from the drug and if the FDA completely withdraws approval those patients may find it hard to get access."

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[smittyc]

Well if Avastin is not efficacious and causes severe side effects, continuing to prescribe it for breast cancer is both cruel and negligent. Why raise false hopes and cause someone to be sick from a drug if it is not effective. Good job FDA.