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Do cancer drugs improve survival or quality of life?

BMJ 2017; 359 doi: (Published 04 October 2017) Cite this as: BMJ 2017;359:j4528
  1. Vinay Prasad, assistant professor of medicine1
  1. 1Oregon Health and Science University, Portland, Oregon, USA
  1. prasad{at}

You don’t need to know, according to our broken regulatory system

When in the lifecycle of a cancer drug should an improvement in survival or quality of life be demonstrated? Some people argue that these benefits should be clearly evident before marketing. Others, me included, believe that for some indications, including terminal cancers with few treatment options, a drug might receive provisional approval based on surrogate outcomes (such as tumour shrinkage or progression-free survival), with overall survival or quality of life assessed after market authorisation. Although there is no consensus, the one answer that seems absolutely unjustifiable is never. And yet, this is often what happens, according to two recent studies.

The first found that between 2008 and 2012 the US Food and Drug Administration approved most uses of cancer drugs without evidence of survival or improved quality of life (67%, 36/54).1 Among the 36 such approvals, only five (14%) uses were shown later to improve survival compared with existing treatments or placebo after a median of 4.4 years on the market.

The linked paper by Davis and colleagues (doi:10.1136/bmj.j4530) extends these findings.2 In their study of cancer drugs approved by the European …

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