Afamitresgene Autoleucel：首次批准。

IF 4.1 3区医学 Q1 GENETICS & HEREDITY

Molecular Diagnosis & Therapy Pub Date : 2024-11-01 Epub Date: 2024-10-15 DOI:10.1007/s40291-024-00749-3

Susan J Keam

{"title":"Afamitresgene Autoleucel：首次批准。","authors":"Susan J Keam","doi":"10.1007/s40291-024-00749-3","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":49797,"journal":{"name":"Molecular Diagnosis & Therapy","volume":" ","pages":"861-866"},"PeriodicalIF":4.1000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Afamitresgene Autoleucel: First Approval.\",\"authors\":\"Susan J Keam\",\"doi\":\"10.1007/s40291-024-00749-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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.\",\"PeriodicalId\":49797,\"journal\":{\"name\":\"Molecular Diagnosis & Therapy\",\"volume\":\" \",\"pages\":\"861-866\"},\"PeriodicalIF\":4.1000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Molecular Diagnosis & Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40291-024-00749-3\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/10/15 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"GENETICS & HEREDITY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Molecular Diagnosis & Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40291-024-00749-3","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/15 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"GENETICS & HEREDITY","Score":null,"Total":0}

引用次数: 0

摘要

Afamitresgene autoleucel（TECELRA®）是一种转基因人类白细胞抗原（HLA）受限的自体黑色素瘤相关抗原4（MAGE-A4）导向T细胞免疫疗法，由Adaptimune Therapeutics plc公司开发，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，用于治疗患有不可切除或转移性滑膜肉瘤的成人患者，这些患者之前接受过化疗，HLA-A*02:01P、-A*02:02P、-A*02:03P或-A*02:06P阳性，并且经FDA批准或通过的配套诊断设备测定，其肿瘤表达MAGE-A4抗原。本文总结了afamitresgene autoleucel在开发过程中取得的里程碑式进展，以及它首次获批用于治疗晚期滑膜肉瘤的原因。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Afamitresgene Autoleucel: First Approval.

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.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Molecular Diagnosis & Therapy 医学-药学

CiteScore

7.80

自引率

2.50%

发文量

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.