{"id":19714,"date":"2026-10-02T09:28:01","date_gmt":"2026-10-02T09:28:01","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=19714"},"modified":"2026-10-02T09:28:01","modified_gmt":"2026-10-02T09:28:01","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-ebvallo-tabelecleucel-date-dautorisation-16-12-2022-revision-8-statut-autorise-titre","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=19714","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Ebvallo, tabelecleucel, Date d\u2019autorisation : 16\/12\/2022, R\u00e9vision : 8, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Ebvallo est un m\u00e9dicament indiqu\u00e9 chez l\u2019adulte et l\u2019enfant \u00e0 partir de 2 ans pr\u00e9sentant une maladie lymphoprolif\u00e9rative post-transplantation positive au virus Epstein-Barr (EBV+ PTLD), survenant apr\u00e8s une greffe d\u2019organe ou de moelle osseuse. Cette pathologie, complication potentiellement mortelle de la transplantation, appara\u00eet dans un contexte d\u2019immunod\u00e9pression li\u00e9e aux traitements anti-rejet, qui favorise l\u2019infection des lymphocytes B par le virus Epstein-Barr et leur transformation en cellules canc\u00e9reuses. Ebvallo est utilis\u00e9 lorsque la maladie r\u00e9cidive ou est r\u00e9fractaire apr\u00e8s au moins un traitement ant\u00e9rieur.<\/p>\n<p>PTLD \u00e9tant une maladie rare, Ebvallo a b\u00e9n\u00e9fici\u00e9 du statut de m\u00e9dicament orphelin dans l\u2019Union europ\u00e9enne depuis le 21 mars 2016 (d\u00e9signation EU\/3\/16\/1627). Le m\u00e9dicament contient la substance active tabelecleucel. Il s\u2019agit de lymphocytes T d\u2019un donneur, pr\u00e9par\u00e9s de mani\u00e8re \u00e0 reconna\u00eetre et d\u00e9truire les lymphocytes B infect\u00e9s par le virus Epstein-Barr chez le patient.<\/p>\n<p>Ebvallo ne peut \u00eatre d\u00e9livr\u00e9 que sur prescription et doit \u00eatre administr\u00e9 sous la surveillance d\u2019un m\u00e9decin exp\u00e9riment\u00e9 en canc\u00e9rologie, dans un environnement disposant de moyens adapt\u00e9s pour la prise en charge d\u2019effets ind\u00e9sirables, y compris en situation d\u2019urgence. Le m\u00e9dicament est administr\u00e9 par perfusion intraveineuse, \u00e0 une posologie adapt\u00e9e au poids corporel, selon des cycles de 35 jours : administration aux jours 1, 8 et 15, avec surveillance jusqu\u2019au jour 35. Le nombre de cycles est ajust\u00e9 en fonction de la r\u00e9ponse au traitement, \u00e9valu\u00e9e vers le jour 28 de chaque cycle.<\/p>\n<p>Sur le plan clinique, l\u2019efficacit\u00e9 d\u2019Ebvallo a \u00e9t\u00e9 d\u00e9montr\u00e9e dans une \u00e9tude principale portant sur 43 patients atteints d\u2019EBV+ PTLD apr\u00e8s greffe d\u2019organe ou de moelle, en \u00e9chec d\u2019au moins un traitement ant\u00e9rieur. Parmi les patients ayant d\u00e9velopp\u00e9 la maladie apr\u00e8s une greffe d\u2019organe solide, 15 sur 29 ont pr\u00e9sent\u00e9 une r\u00e9ponse compl\u00e8te ou partielle, caract\u00e9ris\u00e9e par la disparition ou la r\u00e9duction des signes de cancer. Ces r\u00e9sultats confirment l\u2019int\u00e9r\u00eat de cette th\u00e9rapie cellulaire cibl\u00e9e pour une complication rare mais grave de la transplantation. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/ebvallo\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Ebvallo est un m\u00e9dicament indiqu\u00e9 chez l\u2019adulte et l\u2019enfant \u00e0 partir de 2 ans pr\u00e9sentant une maladie lymphoprolif\u00e9rative post-transplantation positive au virus Epstein-Barr (EBV+ PTLD), survenant apr\u00e8s une greffe d\u2019organe [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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