Magnitude of clinical benefit in trials supporting US Food and Drug Administration (FDA) accelerated approval (AA) and European Medicines Agency (EMA) conditional marketing authorisation (CMA) and subsequent trials supporting conversion to full approval

Background: AA and CMA regulations were established by the US FDA and EMA, respectively, to improve access to drugs for life-threatening diseases. Here, we evaluate the magnitude of clinical benefit as measured by European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) in trials supporting AA and CMA and confirmatory trials supporting conversion to regular approval (RA).