{"id":21543,"date":"2026-10-20T09:51:17","date_gmt":"2026-10-20T09:51:17","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21543"},"modified":"2026-10-20T09:51:17","modified_gmt":"2026-10-20T09:51:17","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-columvi-glofitamab-date-dautorisation-07-07-2023-revision-6-statut-autorise-titre-tra","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21543","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Columvi, glofitamab, Date d\u2019autorisation : 07\/07\/2023, R\u00e9vision : 6, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Columvi est un m\u00e9dicament anticanc\u00e9reux contenant du glofitamab, indiqu\u00e9 chez l\u2019adulte atteint de lymphome diffus \u00e0 grandes cellules B (DLBCL), lorsque la maladie est en rechute ou r\u00e9fractaire apr\u00e8s au moins deux lignes de traitement ant\u00e9rieures. Il a le statut de m\u00e9dicament orphelin depuis le 15 octobre 2021, le DLBCL \u00e9tant une pathologie rare. Chez les adultes pr\u00e9sentant un DLBCL NOS (not otherwise specified), Columvi peut \u00eatre utilis\u00e9 en association avec la gemcitabine et l\u2019oxaliplatine lorsque la maladie est en rechute ou r\u00e9fractaire et que le patient n\u2019est pas \u00e9ligible \u00e0 une autogreffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques.<\/p>\n<p>Le m\u00e9dicament ne peut \u00eatre obtenu que sur prescription et son utilisation doit \u00eatre supervis\u00e9e par un professionnel de sant\u00e9 exp\u00e9riment\u00e9 en oncologie. L\u2019administration doit se faire dans un lieu disposant de moyens m\u00e9dicaux appropri\u00e9s pour prendre en charge d\u2019\u00e9ventuels effets ind\u00e9sirables graves, en particulier le syndrome de lib\u00e9ration de cytokines (CRS), potentiellement mortel, et le syndrome de neurotoxicit\u00e9 associ\u00e9 aux effecteurs immunitaires (ICANS), responsables de troubles neurologiques. Les sympt\u00f4mes de CRS comprennent notamment fi\u00e8vre, vomissements, dyspn\u00e9e, hypotension et c\u00e9phal\u00e9es ; l\u2019ICANS peut se manifester par des troubles de la parole et de l\u2019\u00e9criture, une confusion et des alt\u00e9rations de la conscience.<\/p>\n<p>Columvi est administr\u00e9 par perfusion intraveineuse. La perfusion dure 4 heures pendant les deux premiers cycles, puis peut \u00eatre r\u00e9duite \u00e0 2 heures pour les cycles suivants si la tol\u00e9rance est jug\u00e9e suffisante. Le sch\u00e9ma pr\u00e9voit deux perfusions au premier cycle, puis une perfusion par cycle, chaque cycle durant 21 jours, pour une dur\u00e9e maximale de 12 cycles ou jusqu\u2019\u00e0 progression de la maladie ou survenue d\u2019effets ind\u00e9sirables jug\u00e9s inacceptables. Avant l\u2019introduction de Columvi, les patients doivent recevoir un pr\u00e9traitement par obinutuzumab, destin\u00e9 \u00e0 r\u00e9duire le nombre de lymphocytes B, ainsi que d\u2019autres m\u00e9dicaments visant \u00e0 diminuer le risque de CRS. Les patients doivent \u00eatre surveill\u00e9s pendant et apr\u00e8s chaque perfusion pour d\u00e9tecter des signes de CRS (fi\u00e8vre, tachycardie, vertiges, naus\u00e9es) et la perfusion doit \u00eatre interrompue en cas de CRS. Toute infection doit \u00eatre trait\u00e9e et r\u00e9solue avant de d\u00e9buter Columvi.<\/p>\n<p>Sur le plan m\u00e9canistique, le glofitamab est un anticorps capable de se lier \u00e0 la fois \u00e0 la prot\u00e9ine CD20, pr\u00e9sente \u00e0 la surface des cellules B, y compris tumorales, et \u00e0 la prot\u00e9ine CD3, situ\u00e9e \u00e0 la surface des lymphocytes T. En reliant les cellules B malignes aux lymphocytes T, il favorise l\u2019activation de ces derniers et la destruction des cellules canc\u00e9reuses. Ces \u00e9l\u00e9ments sont susceptibles d\u2019int\u00e9resser le suivi des innovations th\u00e9rapeutiques dans le champ des cancers rares, la r\u00e9gulation des m\u00e9dicaments orphelins et l\u2019organisation des soins sp\u00e9cialis\u00e9s en oncologie, notamment en termes d\u2019exigences de surveillance, de s\u00e9curit\u00e9 d\u2019administration en milieu \u00e9quip\u00e9 et de conditions d\u2019acc\u00e8s pour les patients non \u00e9ligibles \u00e0 la greffe. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/columvi\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Columvi est un m\u00e9dicament anticanc\u00e9reux contenant du glofitamab, indiqu\u00e9 chez l\u2019adulte atteint de lymphome diffus \u00e0 grandes cellules B (DLBCL), lorsque la maladie est en rechute ou r\u00e9fractaire apr\u00e8s au [&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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