In November 2011, the U.S. Food and Drug Administration (FDA) decided that Avastin should no longer be labeled as a breast cance FDA Removes Avastin as Breast Cancer Treatment | Breast Health Resource Center | Imaginis - The Women's Health & Wellness Resource Network

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FDA Removes Avastin as Breast Cancer Treatment

In November 2011, the U.S. Food and Drug Administration (FDA) decided that Avastin should no longer be labeled as a breast cancer treatment. According to a statement by the FDA, Avastin used for metastatic, or advanced, breast cancer has not been shown to provide a benefit, in terms of a delay in tumor growth, that would justify its serious and potentially life-threatening risks. Nor is there evidence that use of Avastin will either help women with breast cancer live longer or improve their quality of life.

The FDA’s decision involves Avastin used in combination with the cancer drug paclitaxel for those patients who have not been treated with chemotherapy for their form of metastatic breast cancer known as HER2 negative. The indication must now be removed from Avastin's product labeling. Avastin will remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancers.

 “This was a difficult decision,” according to a statement released by FDA Commissioner Margaret A. Hamburg, M.D. “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,” Dr. Hamburg said.

Many women were outraged at the FDA’s decision, citing personal benefits from the drug. Analysts expect insurance companies to stop covering the cost of Avastin for breast cancer treatment if the FDA removes its approval. Thus far, insurers appear to be continuing to cover costs of the drug, according to the Centers for Medicare and Medicaid Services.

Avastin is still 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. 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.