Kymriah® (tisagenlecleucel) - An overview of the clinical development journey of the first approved CAR-T therapy

被引：23
|
作者：
Awasthi, Rakesh [1 ,5 ]
Maier, Harald J. [2 ]
Zhang, Jie [3 ]
Lim, Stephen [4 ]
机构：
[1] Novartis Inst Biomed Res, E Hanover, NJ USA
[2] Novartis Pharm AG, Oncol & Hematol, Global Drug Dev, Basel, Switzerland
[3] Novartis Serv Inc, Cell & Gene Unit, E Hanover, NJ USA
[4] Novartis Pharmaceut, US Med Affairs, Oncol, E Hanover, NJ USA
[5] Novartis Inst Biomed Res, Oncol & Hematol, One Hlth Plaza, E Hanover, NJ 07936 USA
来源：
HUMAN VACCINES & IMMUNOTHERAPEUTICS | 2023年 / 19卷 / 01期
关键词：
Cell and gene therapy; CAR-T therapy; clinical development; immunotherapy; leukemia; lymphoma; B-CELL LYMPHOMA; UNITED-STATES; OUTCOMES; JULIET; MANAGEMENT; 2ND-LINE;
D O I：
10.1080/21645515.2023.2210046
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
The emergence of cell and gene therapies has dramatically changed the treatment paradigm in oncology and other therapeutic areas. Kymriah (R) (tisagenlecleucel), a CD19-directed genetically modified autologous T-cell immunotherapy, is currently approved in major markets for the treatment of relapsed/refractory (r/r) pediatric and young adult acute lymphoblastic leukemia, r/r diffuse large B-cell lymphoma, and r/r follicular lymphoma. This article presents a high-level overview of the clinical development journey of tisagenlecleucel, including its efficacy outcomes and safety considerations.
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页数：8
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