SAFETY ALERT: FDA Revokes Approval of Avastin for Use in Breast Cancer

The FDA commissioner, Margaret A. Hamburg, MD, has revoked the approval of Avastin (bevacizumab; Genentech) for the treatment of breast cancer after concluding that the drug has not been shown to be safe and effective for that use. Today's decision, outlined in Dr Hamburg's 69-page memorandum, involves Avastin used in combination with the cancer drug paclitaxel for those patients who have not been treated with chemotherapy for their form of HER2 negative metastatic breast cancer.

Avastin was approved for metastatic breast cancer in February 2008 under the FDA's accelerated approval program, which allows a drug to be approved based on data that are not sufficiently complete to permit full approval. The accelerated approval program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted. If the clinical trials do not justify the continued approval of the drug or a specific drug indication, the FDA may revoke its approval. In this case, the accelerated approval was based on promising results from one study that suggested that the drug could provide a meaningful increase in the amount of time from when treatment is started until the tumor grows or the death of the patient.

After the accelerated approval of Avastin for breast cancer, Genentech completed two additional clinical trials that demonstrated only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone – not enough to outweigh the risk of taking the drug. Avastin's risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines.

For more information visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm280536.htm.