Yi Lin, Lugui Qiu, Saad Usmani, Chng Wee Joo, Luciano Costa, Benjamin Derman, Juan Du, Hermann Einsele, Carlos Fernandez de Larrea, Roman Hajek, P Joy Ho, Efstathios Kastritis, Joaquin Martinez-Lopez, Maria-Victoria Mateos, Joseph Mikhael, Philippe Moreau, Chandramouli Nagarajan, Ajay Nooka, Michael O'Dwyer, Fredrik Schjesvold, Surbhi Sidana, Niels Wcj van de Donk, Katja Weisel, Sonja Zweegman, Noopur Raje, Paula Rodriguez Otero, Larry D Anderson, Shaji Kumar, Tom Martin
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引用次数: 0
摘要
嵌合抗原受体(CAR)T 细胞疗法已在晚期难治性多发性骨髓瘤患者中显示出前景,其反应率从 73% 到 98% 不等。迄今为止,已有三种产品获得批准:其中,Idecabtagene vicleucel(ide-cel)和ciltacabtagene autoleucel(cilta-cel)已获美国食品药品管理局、欧洲药品管理局、加拿大卫生部(仅ide-cel)和巴西ANVISA(仅cilta-cel)批准;equecabtagene autoleucel(eque-cel)已获中国国家医药产品管理局批准。CAR T 细胞疗法不同于以往的抗骨髓瘤疗法,具有独特的毒副作用,需要采取不同的缓解策略。因此,国际骨髓瘤工作组(International Myeloma Working Group)组建了一个专家小组,为CAR T细胞疗法在骨髓瘤中的临床应用提供指导。这份共识意见来自造血细胞移植、细胞疗法和多发性骨髓瘤疗法领域的专家。
Consensus guidelines and recommendations for the management and response assessment of chimeric antigen receptor T-cell therapy in clinical practice for relapsed and refractory multiple myeloma: a report from the International Myeloma Working Group Immunotherapy Committee.
Chimeric antigen receptor (CAR) T-cell therapy has shown promise in patients with late-line refractory multiple myeloma, with response rates ranging from 73 to 98%. To date, three products have been approved: Idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), which are approved by the US Food and Drug Administration, the European Medicines Agency, Health Canada (ide-cel only), and Brazil ANVISA (cilta-cel only); and equecabtagene autoleucel (eque-cel), which was approved by the Chinese National Medical Products Administration. CAR T-cell therapy is different from previous anti-myeloma therapeutics with unique toxic effects that require distinct mitigation strategies. Thus, a panel of experts from the International Myeloma Working Group was assembled to provide guidance for clinical use of CAR T-cell therapy in myeloma. This consensus opinion is from experts in the field of haematopoietic cell transplantation, cell therapy, and multiple myeloma therapeutics.
期刊介绍:
The Lancet Oncology is a trusted international journal that addresses various topics in clinical practice, health policy, and global oncology. It covers a wide range of cancer types, including breast, endocrine system, gastrointestinal, genitourinary, gynaecological, haematological, head and neck, neurooncology, paediatric, thoracic, sarcoma, and skin cancers. Additionally, it includes articles on epidemiology, cancer prevention and control, supportive care, imaging, and health-care systems.
The journal has an Impact Factor of 51.1, making it the leading clinical oncology research journal worldwide. It publishes different types of articles, such as Articles, Reviews, Policy Reviews, Personal Views, Clinical Pictures, Comments, Correspondence, News, and Perspectives. The Lancet Oncology also collaborates with societies, governments, NGOs, and academic centers to publish Series and Commissions that aim to drive positive changes in clinical practice and health policy in areas of global oncology that require attention.