Disparities in the access to immune checkpoint inhibitors approved in the United States, the European Union and mainland China: a serial cross-sectional study
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 diffe...
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BMJ Publishing Group
2025-05-01
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| Series: | BMJ Public Health |
| Online Access: | https://bmjpublichealth.bmj.com/content/3/1/e001995.full |
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| author | Jin-Ling Tang Hao Hu Carolina Oi Lam Ung Shi-Yu Wang Jia-Xin Cai Fu-Xiao Li Teng-Fei Lin Shi-Fu Luo Hai-Bo Song Zhi-Rong Yang Wei-Hua Meng |
| author_facet | Jin-Ling Tang Hao Hu Carolina Oi Lam Ung Shi-Yu Wang Jia-Xin Cai Fu-Xiao Li Teng-Fei Lin Shi-Fu Luo Hai-Bo Song Zhi-Rong Yang Wei-Hua Meng |
| author_sort | Jin-Ling Tang |
| collection | DOAJ |
| description | 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 between trial completion and indication submission were compared using the Kruskal-Wallis test.Results We collected 10 ICIs with 90 indications from the FDA, 10 ICIs with 70 indications from EMA and 16 ICIs with 65 indications from NMPA. Relative lags of ICI indication approval in China (median 344.0 (IQR 220.0, 688.0) days) were longer than in the European Union (118.5 (55.0, 189.0) days) (p<0.0001). Both the European Union (243.0 (191.0, 298.0) days) and China (283.0 (248.0, 339.5) days) demonstrated significantly longer review durations for ICI indications than the United States (181.0 (148.8, 191.8) days) (p<0.0001). While indication submissions to NMPA were significantly more delayed than those to the FDA (p<0.001), the former relied more on trial evidence of OS (84.0%) than the latter (58.0%).Conclusion ICIs approved in the United States, the European Union and mainland China differed in indications, approval time, review duration and evidence base, which may impact access to life-saving treatments. Future studies should investigate the impact of these differences and the underlying reasons beyond the evidence supporting the label approvals. |
| format | Article |
| id | doaj-art-935e2bfd57e44f8fa72c52fffc7238b2 |
| institution | Matheson Library |
| issn | 2753-4294 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Public Health |
| spelling | doaj-art-935e2bfd57e44f8fa72c52fffc7238b22025-07-02T07:15:14ZengBMJ Publishing GroupBMJ Public Health2753-42942025-05-013110.1136/bmjph-2024-001995Disparities in the access to immune checkpoint inhibitors approved in the United States, the European Union and mainland China: a serial cross-sectional studyJin-Ling Tang0Hao Hu1Carolina Oi Lam Ung2Shi-Yu Wang3Jia-Xin Cai4Fu-Xiao Li5Teng-Fei Lin6Shi-Fu Luo7Hai-Bo Song8Zhi-Rong Yang9Wei-Hua Meng10Shenzhen University of Advanced Technology, Shenzhen, Guangdong Province, ChinaThe First Affiliated Hospital of USTC, Division of Life Science and Medicine, University of Science and Technology, Hefei, ChinaState Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Taipa, MacauAlice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, SingaporeNottingham Ningbo China Beacons of Excellence Research and Innovation Institute, University of Nottingham Ningbo China, Ningbo, ChinaDepartment of Computational Biology and Medical Big Data, Shenzhen University of Advanced Technology, Shenzhen, ChinaShenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, Guangdong, ChinaDepartment of Computational Biology and Medical Big Data, Shenzhen University of Advanced Technology, Shenzhen, ChinaNational Center for ADR Monitoring, Beijing, ChinaDepartment of Computational Biology and Medical Big Data, Shenzhen University of Advanced Technology, Shenzhen, ChinaNottingham Ningbo China Beacons of Excellence Research and Innovation Institute, University of Nottingham Ningbo China, Ningbo, ChinaBackground 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 between trial completion and indication submission were compared using the Kruskal-Wallis test.Results We collected 10 ICIs with 90 indications from the FDA, 10 ICIs with 70 indications from EMA and 16 ICIs with 65 indications from NMPA. Relative lags of ICI indication approval in China (median 344.0 (IQR 220.0, 688.0) days) were longer than in the European Union (118.5 (55.0, 189.0) days) (p<0.0001). Both the European Union (243.0 (191.0, 298.0) days) and China (283.0 (248.0, 339.5) days) demonstrated significantly longer review durations for ICI indications than the United States (181.0 (148.8, 191.8) days) (p<0.0001). While indication submissions to NMPA were significantly more delayed than those to the FDA (p<0.001), the former relied more on trial evidence of OS (84.0%) than the latter (58.0%).Conclusion ICIs approved in the United States, the European Union and mainland China differed in indications, approval time, review duration and evidence base, which may impact access to life-saving treatments. Future studies should investigate the impact of these differences and the underlying reasons beyond the evidence supporting the label approvals.https://bmjpublichealth.bmj.com/content/3/1/e001995.full |
| spellingShingle | Jin-Ling Tang Hao Hu Carolina Oi Lam Ung Shi-Yu Wang Jia-Xin Cai Fu-Xiao Li Teng-Fei Lin Shi-Fu Luo Hai-Bo Song Zhi-Rong Yang Wei-Hua Meng Disparities in the access to immune checkpoint inhibitors approved in the United States, the European Union and mainland China: a serial cross-sectional study BMJ Public Health |
| title | Disparities in the access to immune checkpoint inhibitors approved in the United States, the European Union and mainland China: a serial cross-sectional study |
| title_full | Disparities in the access to immune checkpoint inhibitors approved in the United States, the European Union and mainland China: a serial cross-sectional study |
| title_fullStr | Disparities in the access to immune checkpoint inhibitors approved in the United States, the European Union and mainland China: a serial cross-sectional study |
| title_full_unstemmed | Disparities in the access to immune checkpoint inhibitors approved in the United States, the European Union and mainland China: a serial cross-sectional study |
| title_short | Disparities in the access to immune checkpoint inhibitors approved in the United States, the European Union and mainland China: a serial cross-sectional study |
| title_sort | disparities in the access to immune checkpoint inhibitors approved in the united states the european union and mainland china a serial cross sectional study |
| url | https://bmjpublichealth.bmj.com/content/3/1/e001995.full |
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