Home Journals Articles Updates About
CN
image
收藏切换
Research on post-marketing drug risk evaluation and mitigation strategies of CAR-T therapies in US and its implication for China
收藏切换
PDF
Jing WANG, Yun-hong HUANG, Chen-yang ZHAO, Shuang LU, Chen-yan GAO
Chinese Journal of New Drugs | 2023, 32(2) : 128 - 133
Less
收藏切换
Chinese Journal of New Drugs | 2023, 32(2): 128-133
Research on post-marketing drug risk evaluation and mitigation strategies of CAR-T therapies in US and its implication for China
Full
Jing WANG, Yun-hong HUANG, Chen-yang ZHAO, Shuang LU, Chen-yan GAO
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2023-01-30
Outline
收藏切换

"Risk Assessment and Mitigation Strategies" (REMS) are procedures used by the U.S. Food and Drug Administration (FDA) to manage known or potentially serious risks associated with a drug to ensure that the benefits of the drug outweigh its risks. CAR-T cell therapy has brought new hope and new options for cancer patients due to its excellent efficacy. However, due to the characteristics of its treatment principle, almost all CAR-T cell therapy may lead to some adverse reactions. Cytokine release syndrome (CRS) and neurologic toxicities (NT) are the most common. This paper intends to analyze the post-marketing risk management strategies of CAR-T drugs in the United States by exploring the content of REMS in the risk management strategies of CAR-T drugs, and takes Kymriah, a CAR-T product currently on the market in the United States, as an example to analyze the specific implementation of the strategies. The purpose of this paper is to provide reference for the authorities to develop related policies of CAR-T drug listing risk management in China.

risk evaluation and mitigation strategies  /  CAR-T cell therapy  /  risk management  /  cell and gene therapy  /  scientific supervision
Jing WANG, Yun-hong HUANG, Chen-yang ZHAO, Shuang LU, Chen-yan GAO. Research on post-marketing drug risk evaluation and mitigation strategies of CAR-T therapies in US and its implication for China[J]. Chinese Journal of New Drugs, 2023 , 32 (2) : 128 -133 .
Appendix
Less
Year 2023 volume 32 Issue 2
PDF
36
12
Cite this Article
BibTeX
Article Info
  • Online Date：2026-03-05
  • Published：2023-01-30
Article Data
Affiliations
History
  • Accepted：2022-12-22
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
References
Share
https://castjournals.cast.org.cn/joweb/zgxyzz/EN/
Share to
QR

Scan QR to access full text

Cite this article
BibTeX
Citations
表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
关闭全屏
  • BibTeX
  • EndNote
  • RefWorks
  • TxT
Links
Articles
Latest Articles
Most Read
Collections
Updates
Events
News
Multimedia
About
About Us
Contact
No. 86 Xueyuan South Road, Haidian District, Beijing
100081
010-62199257
qkjq@cast.org.cn

Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House