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Cancer drugs remain FDA approved despite lack of benefit, study finds

BMJ 2016; 355 doi: (Published 06 December 2016) Cite this as: BMJ 2016;355:i6568
  1. Michael McCarthy
  1. Seattle

Cancer drugs initially approved by the US Food and Drug Administration on the basis of surrogate endpoints often remain FDA approved even after postmarketing studies find that they neither prolong patients’ lives nor improve their quality of life, a US study has found.

Tracy Rupp and Diana Zuckerman of the National Center for Health Research, a non-profit organization based in Washington, DC, looked at 18 cancer drugs approved by the FDA from 2008 to 2012 on the basis of surrogate endpoints such as tumor shrinkage or progression free survival.1 A previous report showed that postmarketing studies had found that these drugs conferred no overall …

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