FDA Removes Avastin Breast Cancer Indication

Nov 24, 2011

The breast cancer indication for Avastin has been revoked after FDA Commissioner Margaret A. Hamburg concluded that the drug has not been shown to be safe and effective for this use. Avastin’s potential side effects include severe high blood pressure, bleeding and hemorrhaging, heart attack or heart failure, and the development of perforations in different parts of the body. In addition, and there is no evidence that the drug improves quality of life or helps patients to live longer.

“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,” said Hamburg in the FDA’s press statement. “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.”

Avastin will, however, remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer. In its own statement, Genetech also added that it will continue to pursue the potential benefits of Avastin with regards to breast cancer. Hal Barron, chief medical officer and head, Global Product Development, at Genetech said, “Despite today's action, we will start a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin."

An FDA panel voted unanimously to withdraw approval for Avastin earlier this year in June. Hamburg’s final decision is based on extensive data from clinical trials, as well as a 2-day hearing that was requested by Genentech.

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