Potential withdrawal of bevacizumab for the treatment of breast cancer

BMJ 2011; 343 doi: http://dx.doi.org/10.1136/bmj.d4946 (Published 03 August 2011) Cite this as: BMJ 2011;343:d4946
  1. Alison Jones, clinical oncologist1,
  2. Paul Ellis, professor of cancer medicine2
  1. 1Department of Oncology, Royal Free Hospital, London NW3 2QG, UK
  2. 2Department of Cancer Services, Guy’s Hospital, London, UK
  1. alison.jones.md{at}gmail.com

Calls into question the approval of drugs based on surrogate outcomes

On 29 June the oncology drugs advisory committee of the US Food and Drug Administration (FDA) voted unanimously to recommend withdrawing approval of bevacizumab for the treatment of metastatic breast cancer. The panel concluded that bevacizumab (Avastin, Genentech) is neither effective nor safe for the treatment of breast cancer, and the Food and Drug Administration invited public comment on the decision until 28 July before issuing a final ruling. Why has this happened and what implications does it have for the approval and passage of other new cancer drugs into everyday practice?

The success of targeted treatments such as trastuzumab for HER2 positive breast cancer has given rise to the potential for personalised medicine. It is hoped that our understanding of cancer biology and the ability to develop highly specific drugs for molecular targets will generate targeted treatments for individual cancers that result in improved survival combined with less toxicity. Bevacizumab is a humanised monoclonal antibody that inhibits vascular endothelial growth factor A, which is important in stimulating neoangiogenesis in cancer. The efficacy and safety of this drug in patients with first line metastatic breast cancer were shown in a multicentre randomised trial (E2100), which randomised women with metastatic breast cancer to conventional chemotherapy (paclitaxel) alone or in combination with bevacizumab. …

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