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FDA cancels approval for bevacizumab in advanced breast cancer

BMJ 2011; 343 doi: http://dx.doi.org/10.1136/bmj.d7684 (Published 25 November 2011) Cite this as: BMJ 2011;343:d7684
  1. Janice Hopkins Tanne
  1. 1New York

The US Food and Drug Administration last week revoked its approval of bevacizumab (Avastin) for the treatment of metastatic breast cancer. The drug costs about $90 000 (£58 000; €68 000) a year and had created about $3.5bn in sales for its manufacturer, Genentech, annually.

FDA commissioner Margaret Hamburg called it “a difficult decision.” Dr Hamburg said the drug had not been shown to be safe and effective in metastatic breast cancer. She said a review of studies did not show that the drug extended the lives of women with metastatic …

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