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Afamitresgene Autoleucel:首次批准

英文原题:Afamitresgene Autoleucel: First Approval.

PubMed 2024/10/15(内容时间) Mol Diagn Ther Q1 · IF 5.8(JCR 2025)

研究概要

Afamitresgene autoleucel (TECELRA ® ) 是一种经基因修饰的、受人类白细胞抗原 (HLA) 限制的、靶向黑色素瘤相关抗原 4 (MAGE-A4) 的自体 T 细胞免疫疗法,由 Adaptimmune Therapeutics plc 开发,用于治疗表达 MAGE-A4 抗原的实体瘤。

中文摘要

Afamitresgene autoleucel(TECELRA ®)是一种经基因修饰的、HLA限制性的、靶向黑色素瘤相关抗原4(MAGE-A4)的自体T细胞免疫疗法,由Adaptimmune Therapeutics plc开发,用于治疗表达MAGE-A4抗原的实体瘤。2024年8月,afamitresgene autoleucel在美国获得加速批准,用于治疗既往接受过化疗、HLA-A*02:01P、-A*02:02P、-A*02:03P或-A*02:06P阳性且经FDA批准或认可的伴随诊断器械确定肿瘤表达MAGE-A4抗原的不可切除或转移性滑膜肉瘤成人患者。本文总结了afamitresgene autoleucel开发过程中的里程碑事件,这些事件促成了其首次获批用于治疗晚期滑膜肉瘤。

展开英文摘要原文

Afamitresgene autoleucel (TECELRA ® ), a genetically modified human leukocyte antigen (HLA)-restricted autologous melanoma-associated antigen 4 (MAGE-A4)-directed T cell immunotherapy, is being developed by Adaptimmune Therapeutics plc, for the treatment of solid tumours expressing the MAGE-A4 antigen. In August 2024, afamitresgene autoleucel was approved in the USA under accelerated approval for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P or -A*02:06P positive and whose tumour expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. This article summarizes the milestones in the development of afamitresgene autoleucel leading to this first approval for the treatment of advanced synovial sarcoma.

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 Nov
原文标识
PubMed 39404764 · DOI 10.1007/s40291-024-00749-3