Article(id=1236366098711507968, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236366095871955240, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1671638400000, acceptedDateStr=2022-12-22, onlineDate=1772702248503, onlineDateStr=2026-03-05, pubDate=1675008000000, pubDateStr=2023-01-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772702248503, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772702248503, creator=13701087609, updateTime=1772702248503, updator=13701087609, issue=Issue{id=1236366095871955240, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='2', pageStart='113', pageEnd='216', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772702247826, creator=13701087609, updateTime=1772702896580, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236368817010561584, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236366095871955240, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236368817010561585, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236366095871955240, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=128, endPage=133, ext={EN=ArticleExt(id=1236366101140008984, articleId=1236366098711507968, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Research on post-marketing drug risk evaluation and mitigation strategies of CAR-T therapies in US and its implication for China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

"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.

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“风险评估和减轻策略”是美国FDA用于管理与药品相关的已知或潜在的严重风险的一项程序，以确保药物的获益大于其风险。嵌合抗原受体T细胞（CAR-T）疗法因其突出的疗效，为肿瘤患者带来了治疗新希望和新选择，但是由于其治疗原理的特性，目前几乎所有CAR-T细胞治疗都可能导致一些不良反应，其中以细胞因子释放综合征和神经毒性最为常见。本文拟通过探究美国CAR-T类药品风险管理策略中关于风险评估和减轻策略的内容，对美国CAR-T类药品上市后风险管理策略进行分析，并以目前美国上市的Kymriah为例分析其具体实施情况，以期为我国CAR-T类药品上市风险管理的相关政策提供借鉴。

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王晶，女，博士研究生，主要从事生物制品临床审评工作。联系电话：(010)85243063，E-mail: wangjing01@cde.org.cn。

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王晶，女，博士研究生，主要从事生物制品临床审评工作。联系电话：(010)85243063，E-mail: wangjing01@cde.org.cn。

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