FDA Panel Recommends against Avastin for Breast Cancer

An advisory panel to the U.S. Food and Drug Administration (FDA) has recommended that the drug Avastin no longer be administered to breast cancer patients along with chemotherapy. Researchers on the panel found no meaningful benefit for patients who took Avastin and believed the toxicity of the drug outweigh positive effects. The FDA will make the final decision about the drug but often follows the panel’s recommendations. The FDA's decision is expected in mid-September 2010.

The FDA had approved Avastin in 2008 to be used with chemotherapy that includes the drug Taxol in advanced breast cancer patients who have not undergone chemotherapy and whose cancers are not HER-2 positive. HER-2 is a protein found on the surface of breast cancer cells. Some breast cancer patients have extra copies of HER2 that can be associated with more aggressive or treatment-resistant cancers. Another drug, Herceptin, can be used to treat breast cancer patients with HER-2 positive breast cancers.

Avasin is already FDA-approved to treat some colorectal, lung, brain, and kidney cancers. Avastin works by attacking the vascular endothelial growth factor (VEGF) in tumor cells. VEGF enables tumors to grow their own blood supplies, which spur their growth.

At the time the FDA had approved Avastin for breast cancer patients, its advisory panel had recommended against it, stating that Avastin had not been shown to increase patient survival. However, in approving the drug, the FDA noted that Avastin slows the progression of advanced breast cancer. The FDA will make another decision about Avastin shortly.

In July 2010, the panel voted 12 to 1 to remove the drug’s approval for use in breast cancer patients along with chemotherapy. The panel noted that follow-up studies failed to show that it significantly increased the time breast cancer progressed.

Additional Resources and References

• The FDA posted information about medical drugs on its web site at http://www.fda.gov/