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FDA Says Avastin Not Safe or Effective for Patients With Breast Cancer

Ben Leach
Published: Friday, Nov 18, 2011

bevacizumab (Avastin)After months of speculation, FDA Commissioner Margaret A. Hamburg, MD, has made a final decision regarding the use of Avastin (bevacizumab) to treat patients with breast cancer. On November 18, 2011, the commissioner announced that the FDA was withdrawing its approval of the drug to treat patients with breast cancer. The FDA stated that, after further review, it has determined that the drug is not safe or effective when it came to treating breast cancer.

Joyce O’Shaughnessy, MD

“I believe Taxol/Avastin is an excellent treatment for patients with aggressive breast cancer,” said Joyce O’Shaughnessy, MD, co-director of breast cancer research at Baylor Charles A. Sammons Cancer Center in Dallas, Texas, in an interview at the 10th International Congress on The Future of Breast Cancer in California in August. “In the triple-negative subset of patients—many of whom are quite refractory to chemotherapy—where we have fewer options, I especially think that this is the area where Avastin fills its greatest unmet medical need.”

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