Avastin for Breast Cancer Approval Revoked by FDA

Avastin Breast Cancer FDA Decision

On Friday November 18, 2011, the U.S. Food and Drug Administration (FDA) declared the blockbuster drug Avastin should no longer be used in breast cancer patients because there is no proof it extends their lives, and it is causing dangerous side effects.

While Friday’s ruling was long expected, it is sure to disappoint women who say they have 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.

Avastin will not stop selling, as it is also used to treat colon cancer and certain other tumors, but the FDA ruling is expected to influence insurance coverage in the U.S.

However, Brian Cook, spokesman for the Centers for Medicare & Medicaid Services said: “Medicare will continue to cover Avastin. The agency will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies.”

Including infusion fees, a year’s treatment with Avastin can reach $100,000. The Avastin saga began in 2008, when an initial study suggested the drug could delay tumor growth for a few months in women whose breast cancer had spread to other parts of the body. Over the objection of its own advisers and to the surprise of cancer groups, FDA gave Avastin conditional approval, and it could be sold for such women while manufacturer Genentech tried to prove it really worked.

Diana Zuckerman of the National Research Center for Women and Families in Washington, said: “The science is clear: Breast cancer patients are more likely to be harmed than helped by Avastin.”

The breast cancer organization Susan G. Komen for the Cure said that it respected the FDA’s decision and that it was time for researchers to concentrate on finding so-called biomarkers that would tell which drug is right for which patient.

Dr. Neal Meropol of University Hospitals Case Medical Center in Cleveland, who has long used Avastin for colon cancer, said: “Each type of cancer is very different from another in important ways, and in the end it’s no surprise that Avastin’s effectiveness may not be equivalent against all types of cancer.”

If your insurer is ending Avastin coverage for breast cancer, you can seek financial help from Genentech’s access program.

Related posts:

1. Breast Cancer in Black Women: Higher Risk of Second Breast Cancer According to New Study
2. Breast Cancer Awareness Month 2011

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