A retrospective cohort study has assessed the available evidence for overall survival and quality-of-life benefits from clinical trials of cancer drugs approved by the European Medicines Agency (EMA) between January 2009 and December 2013.¹

The authors reviewed regulatory documentation from the EMA’s website to identify all cancer drugs approved during the study period.¹ Approvals included first marketing authorisations and new indications. Overall survival and quality of life data for the relevant cancer drugs were extracted from published ‘pivotal’ trials used for marketing approval and post-marketing trials in order to evaluate outcomes at the time of approval and during the subsequent post-marketing …