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La Revue de médecine interne, v.40 no.8, 2019년, pp.545 - 552
Chabannon, C. (Institut Paoli-Calmettes (IPC)) , Bouabdallah, R. (Institut Paoli-Calmettes (IPC)) , Fürst, S. (Institut Paoli-Calmettes (IPC)) , Granata, A. (Institut Paoli-Calmettes (IPC)) , Saillard, C. (Institut Paoli-Calmettes (IPC)) , Vey, N. (Institut Paoli-Calmettes (IPC)) , Mokart, D. (Institut Paoli-Calmettes (IPC)) , Fougereau, E. (Institut Paoli-Calmettes (IPC)) , Lemarie, C. (Institut Paoli-Calmettes (IPC)) , Mfarrej, B. (Institut Paoli-Calmettes (IPC)) , Blaise, D. (Institut Paoli-Calmettes (IPC)) , Calmels, B. (Institut Paoli-Calmettes (IPC))
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Abstract CAR-T cells are genetically modified human lymphocytes and gene therapy medicinal products. They are developed to treat cancers that express a membrane antigen targeted by the CAR. The FDA approved the two first-in-class medicinal products in 2017 and EMA in August 2018; both are autologou...
Résumé Les lymphocytes T humains génétiquement manipulés pour exprimer un récepteur chimérique à l’antigène sont des médicaments de thérapie génique développés pour traiter des maladies tumorales caractérisées par l’expression membranaire d’un antigène ciblé par le récepteur chimérique. Les deux premiers médicaments dans cette classe ont obtenu une autorisation de mise sur le marché aux États-Unis en 2017 et eu Europe en août 2018. Dans les deux cas il s’agit de CAR-T cells autologues, ciblant l’antigène CD19 exprimé tout au long de la différenciation B et sur les hémopathies lymphoïdes B. Leur efficacité clinique a été démontrée chez des patients atteints de leucémies aiguës lymphoblastiques B, de lymphomes malins non-Hodgkinien B et de leucémies lymphoïdes chroniques réfractaires ou à des stades avancés, bien que les termes des deux AMM soient plus restrictifs sur les indications. La production de ces traitements personnalisés nécessite une organisation inédite prenant en compte la sécurité du produit, celle du patient et le respect d’un cadre réglementaire complexe. Les effets secondaires peuvent être aussi spectaculaires que l’efficacité : leur bonne prise en charge nécessite un apprentissage et une étroite collaboration entre spécialistes de différentes disciplines, mais particulièrement entre hématologistes et réanimateurs. Le coût très élevé de ces médicaments s’inscrit dans une tendance lourde de renchérissement significatif pour l’accès aux innovations en hématologie et en oncologie, mais soulève la question de la capacité des systèmes de soins à assumer ces dépenses nouvelles.
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