Obecabtagene Autoleucel: First Approval.

IF 4.1 3区 医学 Q1 GENETICS & HEREDITY
Molecular Diagnosis & Therapy Pub Date : 2025-05-01 Epub Date: 2025-01-31 DOI:10.1007/s40291-025-00771-z
Arnold Lee
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引用次数: 0

Abstract

Obecabtagene autoleucel (AUCATZYL®) is a CD19-directed genetically modified autologous T cell immunotherapy which is being developed by Autolus for the treatment of hematological cancers and systemic lupus erythematosus. In comparison with other chimeric antigen receptor T (CAR T) therapies, obecabtagene autoleucel has a fast off-rate binder for CD19. Obecabtagene autoleucel received approval following positive results from the FELIX phase I/II trial in adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), and it is the first CAR T therapy that does not have mandatory Risk Evaluation Mitigation Strategy monitoring requirements. This article summarizes the milestones in the development of obecabtagene autoleucel leading to this first approval for the treatment of adults with relapsed or refractory B-cell precursor ALL.

obbecabtagene autoleuel:首次批准。
Obecabtagene autoeucel (AUCATZYL®)是一种cd19导向的转基因自体T细胞免疫疗法,由Autolus公司开发,用于治疗血液病和系统性红斑狼疮。与其他嵌合抗原受体T (CAR - T)疗法相比,obbecabtagene自体甲醇具有一种快速的CD19脱速结合剂。Obecabtagene autoleuel在FELIX治疗复发或难治性b细胞前体急性淋巴细胞白血病(ALL)的成人I/II期试验中取得阳性结果后获得批准,这是第一个没有强制性风险评估缓解策略监测要求的CAR - T疗法。这篇文章总结了obbecabtagene autoeucel的发展里程碑,导致该药物首次被批准用于治疗复发或难治性b细胞前体ALL。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
7.80
自引率
2.50%
发文量
53
审稿时长
>12 weeks
期刊介绍: Molecular Diagnosis & Therapy welcomes current opinion articles on emerging or contentious issues, comprehensive narrative reviews, systematic reviews (as outlined by the PRISMA statement), original research articles (including short communications) and letters to the editor. All manuscripts are subject to peer review by international experts.
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