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The US Food and Drug Administration (FDA) is revoking the approval of Avastin® (bevacizumab) for the treatment breast cancer. The FDA concluded that Avastin has not been shown to be safe and effective for this purpose. This decision does not affect the use of Avastin for other approved purposes.

Avastin is a targeted therapy that blocks a protein known as VEGF. VEGF plays a key role in the development of new blood vessels. By blocking VEGF, Avastin deprives the cancer of nutrients and oxygen and inhibits its growth. Although Avastin is no long approved for breast cancer, it is still approved for use in selected patients with lung cancer, colorectal cancer, kidney cancer, or glioblastoma.

For breast cancer, Avastin was approved in 2008 under the FDA’s accelerated approval program. The accelerated approval program provides earlier access to promising drugs for life-threatening health conditions while confirmatory studies are conducted. The approval was for use of Avastin in combination with chemotherapy (paclitaxel) for women who had not received chemotherapy for metastatic, HER2-negative breast cancer. The approval was based on the finding that Avastin delayed the progression (worsening) of metastatic breast cancer. There was no evidence that Avastin improved overall survival.

Since Avastin’s approval for breast cancer, results from additional studies have been reported to the FDA. These studies found that Avastin had only a small effect on rate of cancer progression and no effect on overall survival. The FDA concluded that the potential benefits of Avastin for breast cancer do not outweigh the risks. Risks of Avastin include severe high blood pressure; bleeding problems; the development of perforations (holes) in the nose, stomach, and intestines; and heart attack or heart failure.

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It remains possible that Avastin will be found to benefit specific subgroups of breast cancer patients, and the FDA noted that it is open to considering data from additional studies that address this question.

Reference: FDA News Release. FDA Commissioner announces Avastin decision. November 18, 2011.

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