Intended for healthcare professionals


FDA cancels approval for bevacizumab in advanced breast cancer

BMJ 2011; 343 doi: (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 breast cancer and women taking it risked life threatening side effects such as severe hypertension, bleeding, heart attack, or heart failure, and perforations of the nose, stomach, and intestine.

The European Medicines Agency has approved bevacizumab with paclitaxel for treating metastatic breast cancer but the UK’s National Institute for Health and Clinical Excellence has not recommended its use with taxane drugs as first line treatment for the condition.

The FDA quickly approved bevacizumab for breast cancer in 2008 under its accelerated approval programme while studies were continuing. Those studies showed only a small effect on tumour growth and patients did not live longer or have a better quality of life than those taking standard chemotherapy.

In June 2011 an FDA advisory panel recommended the drug be withdrawn but Genentech objected and in public hearings patients pleaded for the drug that they said was keeping them alive. Last week the FDA finally revoked its approval for bevacizumab in breast cancer.

The drug, which blocks blood vessel growth to tumours, is still approved for use in colorectal cancer, non-small cell lung cancer, glioblastoma, and renal cancer.

Dr Hamburg said patients should ask questions and demand explanations about the drugs used to treat them. She offered words of sympathy, saying how difficult it was for patients and their families to cope with metastatic breast cancer and expressing hope for more effective treatments. However, she said patients must have confidence that FDA approved drugs are safe and effective for their intended use.

The FDA’s decision has no direct effect on health insurance or medical practice, neither of which it regulates.

However, health insurance companies may decide not to reimburse patients for the drug, although doctors may continue to prescribe it “off label” for breast cancer patients.

Medicare, the health insurance programme for older people, said it would continue to pay for the drug but would monitor the situation.

Genentech, the manufacturer, said it was considering conducting a new phase III clinical trial to see which patients might be helped by the drug.


Cite this as: BMJ 2011;343:d7684


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