期刊
CURRENT OPINION IN ONCOLOGY
卷 32, 期 5, 页码 427-433出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/CCO.0000000000000665
关键词
CAR T cells or chimeric antigen receptor T cells; real world data; registry
类别
资金
- Institut Paoli-Calmettes [CBT-1409]
- AIRC [Ig 18458]
- AIRC 5 per Mille [22737]
- Italian Ministry of Research and University [PRIN 2017WC8499]
- Italian Ministry of Health
- KWF [UU 2015-7601 2017-11393, 2019-11979, 201912586]
Purpose of review With the approval of the first chimeric antigen receptor (CAR)-T cell products on the market, the European Medicines Agency (EMA) required market authorization holders (MAHs) to monitor the long-term efficacy and safety of CAR-T cells for 15 years after administration. In 2019, the cellular therapy module of the European Society for Blood and Marrow Transplantation (EBMT) registry received a positive qualification opinion from the EMA indicating that the registry fulfills the essential needs to capture such data. We investigated its broader implication. Recent findings Since 2020, the cellular therapy module of the EBMT registry captures data to support postauthorization studies for MAHs and EMA. The process toward a positive qualification opinion has attracted interest from many other stakeholders, such as scientists and Health Technology Assessment bodies, and was the spin-off for a stimulating development which defined the need for a registry to comply with regulatory requirements, and also inspired ways to deal with CAR-T cell programs in terms of center qualifications and educational standards for professionals. The positive qualified opinion of the EBMT registry by EMA to monitor long-term efficacy and safety of commercial CAR-T cells created opportunities and challenges and was serving as linking-pin to launch a novel CAR-T cell community.
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