FDA Set to Drop Approval of Avastin for Breast Cancer

Says drug does not help patients live longer
By Mark Russell,  Newser Staff
Posted Dec 17, 2010 10:19 AM CST
FDA Set to Drop Approval of Avastin for Breast Cancer
Genentech's anti-cancer drug Avastin could lose its FDA approval for treating breast cancer.   (AP Photo/Paul Sakuma)

The FDA is moving to revoke its approval of Avastin for the treatment of advanced-stage breast cancer, concluding that the drug doesn't help patients live longer, reports the Washington Post. Regulators took their initial steps yesterday against Avastin, which is the best-selling cancer drug in the world but also one of the most expensive: The 17,500 breast cancer patients who take it each year spend about $8,000 per month to do so.

Avastin was the first of a new class of cancer-fighting drugs that work by blocking blood flow to tumors. But new studies said the drug did little to extend patient life, often slowing tumor growth for as little as a month, while causing serious side effects such as high blood pressure, heart failure, and hemorrhages. Even if the FDA withdraws approval of Avastin for breast cancer, it will remain available for other types of cancer; doctors could still prescribe it for breast cancer, but without FDA approval, insurers likely wouldn't cover it. Avastin's manufacturer, Genentech, has said it will seek a review of the ruling, the first time a company has challenged the FDA on such a decision.

(More Avastin stories.)

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