1. [CAR-T CELLS: How does the EBMT registry monitor European activities, identify hurdles and prepare for changes in regulations]
- Author
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Christian, Chabannon, Jessica, Lemaitre, Régis, Peffault de Latour, Bénédicte, Neven, Jacques-Olivier, Bay, Marie, Robin, Jurgen, Kuball, Sofie, Terwel, Mohamad, Mohty, and Ibrahim, Yakoub-Agha
- Subjects
Europe ,Marketing ,Receptors, Chimeric Antigen ,Data Collection ,T-Lymphocytes ,Humans ,Registries ,Immunotherapy, Adoptive - Abstract
CAR-T Cells are gene therapy medicinal products, a subcategory of Advanced Therapy Medicinal Products as defined in the EC Regulation 1394/2007. They may represent the first example of such medicinal products that are industry-manufactured and commercialized on a large scale. Their very nature, their manufacturing processes, pricing and conditions upon which they were approved by regulatory agencies, all lead the latter to require long-term follow-up after marketing approval with a view for a better definition of CAR-T Cells safety profile and efficacy profile in real world conditions. Collection and analysis of data over a 15-year period of time represents a technical and political challenge. So does the a priori definition of data to be collected for a wealth of forthcoming analyses that focus on the interests of a variety of stakeholders. EBMT has been collecting and analyzing data on hematopoietic cell transplants for decades. EBMT currently works with many interested parties to collect data on patients treated with CAR-T Cells.
- Published
- 2021