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Opportunities and challenges associated with the evaluation of chimeric antigen receptor T cells in real-life
Author(s) -
Eoin McGrath,
Christian Chaban,
Sofie Terwel,
Chiara Bonini,
Jürgen Kuball
Publication year - 2020
Publication title -
current opinion in oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.297
H-Index - 95
eISSN - 1080-8140
pISSN - 1040-8746
DOI - 10.1097/cco.0000000000000665
Subject(s) - chimeric antigen receptor , computational biology , antigen , computer science , microbiology and biotechnology , biology , immunology , immunotherapy , immune system
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.

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