FDA Commissioner Removes Breast Cancer Indication from Avastin Label

FDA Commissioner Removes Breast Cancer Indication from Avastin Label

FDA Commissioner Margaret Hamburg is revoking the agency’s accelerated approval of the breast cancer indication for Avastin (bevacizumab), manufactured by Genentech.   Avastin used for metastatic breast cancer has not been shown to provide a benefit, in terms of delay in the growth of tumors, that would justify its serious and potentially life-threatening risks. Nor is there evidence that use of Avastin will either help women with breast cancer live longer or improve their quality of life.

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