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lifileucel:首次获批

英文原题:Lifileucel: First Approval.

PubMed 2024/04/16(内容时间) Mol Diagn Ther Q1 · IF 5.8(JCR 2025)

研究概要

Lifileucel(AMTAGVI)是一种一次性自体 T 细胞疗法,由取自患者自身肿瘤的TIL(肿瘤浸润淋巴细胞)衍生并扩增而来,正由 Iovance Biotherapeutics, Inc. 开发。

中文摘要

Lifileucel(AMTAGVI)是一种一次性自体T细胞疗法,由患者自身肿瘤中的TIL(肿瘤浸润淋巴细胞)提取并扩增而成,目前由Iovance Biotherapeutics, Inc.开发用于癌症治疗。2024年2月,美国基于客观缓解率(ORR)给予lifileucel加速批准,用于既往接受PD-1阻断抗体治疗后病情进展的不可切除或转移性黑色素瘤成人患者;若患者携带BRAF V600突变,还须既往接受BRAF抑制剂治疗,可联合或不联合MEK抑制剂。本文总结lifileucel的研发里程碑,并介绍其首次获批用于既往抗PD-1/L1治疗及靶向治疗后进展的不可切除或转移性黑色素瘤患者的历程。

展开英文摘要原文

Lifileucel (AMTAGVI ), a one-time autologous T cell therapy derived and expanded from tumour-infiltrating lymphocytes (TIL) from a patient's own tumour, is being developed by Iovance Biotherapeutics, Inc. for the treatment of cancer. Lifileucel was granted accelerated approval based on objective response rate (ORR) in February 2024 in the USA for use in adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This article summarizes the milestones in the development of lifileucel leading to this first approval for the treatment of patients with unresectable or metastatic melanoma who have progressed on or after prior anti-PD-1/L1 therapy and targeted 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 & therapy2024 May
原文标识
PubMed 38625642 · DOI 10.1007/s40291-024-00708-y