FDA: Avastin No Longer Approved for Breast Cancer

An FDA panel voted unanimously to pull approval for the use of Avastin (bevacizumab) in breast cancer, an extension of its June ruling in which the agency began the process of withdrawing approval of the drug for metastatic breast cancer. It is still approved for use in colon, lung, kidney, and brain cancer.

FDA Commissioner Margaret Hamburg, MD, said the risks of the drug far outweighed its benefits. In a statement from the FDA, Hamburg 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 risk. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.

The drug's manufacturer had argued that the drug be continued for metatastic triple-negative breast cancer, which has few options. That option was dismissed by the FDA. Commissioner Hamburg did encourage more research on the drug's effectiveness for advanced breast cancer. In December, 2010, when the FDA first considered pulling the drug, I argued:

More research is needed specifically on Avastin and triple-negative. This requires a change in focus, but that focus might ultimately yield enough evidence to demonstrate the drug's effectiveness--or lack thereof--for this important and specific subgroup.