FDA Revokes Approval of Breast Cancer Drug Avastin

Citing severe side effects and health risks that include heart failure, FDA pulls approval of drug used for advanced breast cancer

After originally approving cancer drug Avastin in 2008 to treat metastatic breast cancer, the U.S. Food and Drug Administration (FDA) has rescinded that approval, saying it is neither safe nor effective to treat breast cancer. Avastin, made by Genentech, still maintains FDA approval for treating other cancers of the colon, kidney, brain and lungs.

FDA commissioner Margaret A. Hamburg, M.D., released a 69-page opinion on why the approval was reneged. Addressing today’s decision she said: “This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use… After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.”

Some of the side effects of Avastin include severe high blood pressure, bleeding, hemorrhaging and heart attack or heart failure.

Following the FDA’s announcement, Susan G. Komen for the Cure also released a statement:

“As a patient advocacy organization, we want to ensure that women who are successfully using Avastin today continue to have access to the drug, and that their treatment be covered by third-party payers.

This decision underscores the need for aggressive research to develop treatments that will allow women to live full, high-quality lives even with advanced and metastatic breast cancers. At the same time, we encourage continued research into biomarkers that will help identify which patients will or will not benefit from certain treatments.”

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