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FDA Commissioner Revokes Approval of Avastin for Breast Cancer

November 18, 2011

Today, FDA Commissioner Margaret Hamburg, MD, announced her decision to revoke the agency’s approval of the breast cancer indication for Avastin (bevacizumab).  According to Dr. Hamburg, “After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.”  This long-expected decision comes after more than a year of deliberations and a public hearing in June where the Oncologic Drugs Advisory Committee voted unanimously against Genetech's appeal.  Read NBCC's Statement here.