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FDA Decides to Reject Avastin for Breast Cancer Treatment

The FDA has decided to remove the breast cancer indication from the Avastin label, citing that the drug has not be shown to be safe or effective in breast cancer patients. Avatin has been on the market for 2 years to treat breast cancer, but an advisory panel to the FDA recommended last July 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 stated the following in a news release announcing its decision: “The agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.”

Avastin is already FDA-approved to treat some colorectal, lung, brain, and kidney cancers. The FDA advised that doctors currently treating patients with Avastin for advanced breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.

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. 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.

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. 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.


The December 16, 2010 FDA news release, “FDA begins process to remove breast cancer indication from Avastin label ,” was published on the FDA web site,