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.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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