Cancer drug applications to the EMA and the FDA: A comparison of new drugs and extension of indication in terms of approval decisions and time in review.

Aims: The aim of this study was to compare the final approval decision and time from submission to final decision for new drug applications and applications for extension of indications to the EMA and the FDA within cancer drugs.

Methods: We performed a retrospective analysis on antineoplastic drug applications with a final decision in both the EMA and the FDA from January 1, 2018, to December 31, 2022. For each included drug application, we collected data from the EMA website and the Drugs@FDA database.

Results: A total of 48 new drug applications and 94 applications for extension were included. Agreement in the final decision between the EMA and the FDA was found in 94% of new drug applications and 96% of applications for extension. For new drug applications, the time from submission to approval in the EMA and the FDA were median (interquartile range, IQR) 424 (394-481) days and 216 (169-243) days, respectively. For extensions, the median time from submission to approval in the EMA and the FDA were 295 (245-348) days and 176 (140-183) days, respectively.

Conclusions: We found a high agreement in final approval decisions for cancer drug applications between the EMA and the FDA both for new drug applications and applications for extension. The time from submission to the final decision was markedly shorter in the FDA than in the EMA, albeit the difference was smaller for extensions than for new drug applications. The results indicate that the longer time from submission to decision in the EMA than in the FDA has limited influence on the final approval decisions.