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Equecabtagene Autoleucel:首次获批

英文原题:Equecabtagene Autoleucel: First Approval.

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Equecabtagene Autoleucel: First Approval.

PubMed 2023/09/02(内容时间) Mol Diagn Ther Q1 · IF 5.8(JCR 2025)

研究概要

Equecabtagene autoleucel(Fucaso)是一种自体抗B细胞成熟抗原(BCMA)导向的嵌合抗原受体(CAR)-T细胞疗法,使用慢病毒作为基因载体转染自体T细胞,由IASO Biotechnology和Innovent Biologics, Inc.开发。

中文摘要

Equecabtagene autoleucel(Fucaso)是一种自体抗 B 细胞成熟抗原(BCMA)嵌合抗原受体(CAR)T 细胞疗法,使用慢病毒作为基因载体转导自体 T 细胞,由 IASO Biotechnology 和 Innovent Biologics, Inc. 开发,用于治疗多发性骨髓瘤(MM)及神经系统自身免疫病,包括视神经脊髓炎谱系疾病(NMOSD)。2023 年 6 月,中国有条件批准 equecabtagene autoleucel 用于既往接受 3 线治疗后(包括 1 种蛋白酶体抑制剂和 1 种免疫调节剂)仍进展的成人复发或难治性 MM(RRMM)患者。本文总结了 equecabtagene autoleucel 的开发里程碑,并介绍其首次获批用于多线治疗后进展 RRMM 患者的过程。

展开英文摘要原文

Equecabtagene autoleucel (Fucaso ), an autologous anti-B cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)-T cell therapy that uses lentivirus as a gene vector to transfect autologous T cells, is being developed by IASO Biotechnology and Innovent Biologics, Inc. for the treatment of multiple myeloma (MM) and autoimmune diseases of the nervous system, including neuromyelitis optica spectrum disorder (NMOSD). Equecabtagene autoleucel was granted conditional approval in China in June 2023 for the treatment of adults with relapsed or refractory MM (RRMM) who have progressed after 3 lines of therapy ( 1 proteasome inhibitor and an immunomodulator). This article summarizes the milestones in the development of equecabtagene autoleucel leading to this first approval in patients with RRMM who have progressed after multiple lines of therapy.

论文信息

作者
Keam SJ
单位
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. mdt@adis.com.Iran
文献类型
综述
期刊
Molecular diagnosis & therapy2023 Nov
原文标识
PubMed 37658205 · DOI 10.1007/s40291-023-00673-y