FDA Denies Avastin Treatment for Breast Cancer

Washington, DCThe FDA has denied Roche, the manufacturer of Avastin, to use its top selling-cancer drug as a treatment for breast cancer therapy. The decision has ended a year-long battle between Roche, the FDA and health professionals, who argued whether Avastin’s benefits outweighed the risks.

In June 2011, an advisory panel of “outside cancer experts” voted 6-0 against Avastin's use in breast cancer, and on November 18, FDA Commissioner Margaret Hamburg ended the debate. "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,” said Hamburg, adding that there is no evidence indicating that using Avastin will help women improve their quality of life or help them live longer.

Avastin was approved by the FDA to treat breast cancer in 2008, but the approval was accelerated on condition that Roche conducted follow-up studies to confirm the drug’s benefit. However, those studies failed to prove that Avastin prolonged the lives of breast cancer patients. Studies did show that Avastin is associated with severe side effects, including blood clots, bleeding, and holes in the stomach and intestines.

Roche said they are “disappointed” with the decision. The drug company said a new phase III study of Avastin in combination with chemotherapy is planned, which will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin. Avastin sales worldwide were $6.2 billion last year, of which about $800 million to $1 billion of that amount came from breast cancer treatment.