Disparities in the access to immune checkpoint inhibitors approved in the United States, the European Union and mainland China: a serial cross-sectional study.

ABSTRACT:

Background

Immune checkpoint inhibitors (ICIs) have revolutionised antitumour therapy. However, regional differences in ICI labels, including the impact of the review process and supporting trial evidence, remain unclear.

Methods

We conducted a serial cross-sectional study to examine trends and differences in indication approvals and associated clinical trials for ICIs across different regulatory agencies. We searched ICI labels approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and National Medical Products Administration (NMPA) in Mainland China before 31 December 2022 and assessed the indications and clinical trials in labels. Relative lags of indication approvals were compared using the Mann-Whitney U test. The review time and interval be

SUBMITTER: Cai JX 

PROVIDER: S-EPMC11911679 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature