Little confidence in bevacizumab

Published: 2010-09-24

Despite a five-to-four vote against approval by its advisory committee on 22 February 2008, the FDA approved bevacizumab for patients with metastatic breast cancer under their accelerated drug approval programme. This approval was based on a single trial of bevacizumab added to chemotherapy and was made with the proviso that further ongoing trials be completed.

These additional trials have now reported and suggest the FDA got it wrong in approving this drug on such limited evidence. None of the trials have shown an overall survival benefit. As a result, the FDA Oncologic Drugs Advisory Committee voted 12-to-one in July 2010, recommending the withdrawal of marketing approval and stating that the benefit for progression does not outweigh the additional toxicity. The FDA has just announced postponement of its decision whether or not to withdraw bevacizumab’s marketing authorisation, leaving doctors and patients in limbo.