Friday, November 18, 2011 (Last Updated: 11/21/2011)
FRIDAY, Nov. 18 (HealthDay News) -- The U.S. Food and Drug Administration is revoking its accelerated approval of Avastin for the treatment of breast cancer after finding the drug neither safe nor effective for that indication, according to a Nov. 18 press release from the agency.
Avastin was granted accelerated approved for metastatic breast cancer in 2008 based on promising results from one study that suggested the drug could increase the duration of time from the start of treatment to tumor growth or death of the patient. Subsequent trials by the drug's manufacturer, Genentech, failed to duplicate these findings.
Consequently, the agency decided that the results of the new trials did not justify continued approval of Avastin, which carries serious and potentially lethal risks. This indication of its use for breast cancer treatment will be removed from the product's label. Avastin will remain on the market for the treatment of other forms of cancer.
"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," Margaret A. Hamburg, M.D., FDA Commissioner, said in a statement.
Hematology & Oncology
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