Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021

Between 2007 and 2021, only 38.9% of drug indications granted accelerated approval in the US and 37.5% of those granted conditional marketing authorization in the EU demonstrated high added therapeutic value at the time of approval, with cancer indications showing substantially lower therapeutic value compared to noncancer indications. Policymakers and regulators should strengthen enforcement of timely confirmatory studies for drugs approved through these expedited pathways.