Expedited pathway insights: Unveiling oncology and non-oncology drug approvals and withdrawals of USFDA and EMA

Background

Prior to entering the market, health authorities conduct a rigorous evaluation of compiled information for drugs delaying its entry. To address this void expedited pathways are introduced.

Methods

In this study, both oncology and non-oncology drugs approved through various expedited pathways from the US and Europe have been scrutinized using the USFDA’s Novel Drug approvals from 2020 to 2023 and EMA’s Human Medicine Highlights 2020 to 2023. Withdrawals if any along with factors causing withdrawal have also been studied.

Results

Among all the pathways accelerated approval has high oncological drug approvals and also high withdrawal for drugs approved based on surrogate endpoints. From the study conducted it was observed that intensive evaluation has to be performed both pre and post-approval for drugs approved based on surrogate endpoints as well as on the conduct of their confirmatory trials.