{"id":19711,"date":"2026-10-02T13:08:50","date_gmt":"2026-10-02T13:08:50","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=19711"},"modified":"2026-10-02T13:08:50","modified_gmt":"2026-10-02T13:08:50","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-ordspono-odronextamab-date-dautorisation-22-08-2024-revision-2-statut-autorise-titre","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=19711","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Ordspono, odronextamab, Date d\u2019autorisation : 22\/08\/2024, R\u00e9vision : 2, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Ordspono est un m\u00e9dicament anticanc\u00e9reux indiqu\u00e9 chez l\u2019adulte pour le traitement du lymphome folliculaire et du lymphome diffus \u00e0 grandes cellules B (DLBCL), deux formes de cancers du sang. Il est utilis\u00e9 lorsque la maladie est en rechute ou r\u00e9fractaire apr\u00e8s au moins deux lignes de traitements syst\u00e9miques ant\u00e9rieurs.<\/p>\n<p>Le m\u00e9dicament contient la substance active odronextamab. Il s\u2019agit d\u2019un anticorps bisp\u00e9cifique qui se fixe simultan\u00e9ment sur la prot\u00e9ine CD20 pr\u00e9sente \u00e0 la surface des lymphocytes B (y compris les cellules tumorales) et sur la prot\u00e9ine CD3 \u00e0 la surface des lymphocytes T. Ce double ciblage rapproche cellules canc\u00e9reuses et lymphocytes T, activant ces derniers afin qu\u2019ils d\u00e9truisent les cellules tumorales.<\/p>\n<p>Ordspono est soumis \u00e0 prescription m\u00e9dicale et son administration doit \u00eatre assur\u00e9e et surveill\u00e9e par un professionnel de sant\u00e9 exp\u00e9riment\u00e9 en canc\u00e9rologie, dans un environnement disposant de moyens adapt\u00e9s pour prendre en charge un syndrome de lib\u00e9ration de cytokines, complication potentiellement grave pouvant associer fi\u00e8vre, vomissements, dyspn\u00e9e, c\u00e9phal\u00e9es et hypotension.<\/p>\n<p>Le traitement est administr\u00e9 par perfusion intraveineuse selon un sch\u00e9ma par cycles de 21 jours. Les quatre premiers cycles constituent la phase initiale : au premier cycle, les perfusions sont r\u00e9alis\u00e9es aux jours 1, 2, 8, 9, 15 et 16 avec des doses progressives ; aux cycles 2 \u00e0 4, les perfusions ont lieu aux jours 1, 8 et 15. Par la suite, Ordspono est administr\u00e9 toutes les 2 ou 4 semaines, en fonction de la r\u00e9ponse du patient, jusqu\u2019\u00e0 progression de la maladie ou survenue d\u2019effets ind\u00e9sirables jug\u00e9s inacceptables. Des m\u00e9dicaments pr\u00e9ventifs sont administr\u00e9s avant et apr\u00e8s certaines perfusions durant les deux premiers cycles, voire au-del\u00e0 si n\u00e9cessaire, afin de r\u00e9duire le risque de syndrome de lib\u00e9ration de cytokines et de r\u00e9actions li\u00e9es \u00e0 la perfusion. Le m\u00e9decin peut reporter certaines doses ou interrompre d\u00e9finitivement le traitement en cas d\u2019effets ind\u00e9sirables sp\u00e9cifiques ou s\u00e9v\u00e8res.<\/p>\n<p>Les donn\u00e9es d\u2019efficacit\u00e9 proviennent d\u2019une \u00e9tude principale non comparative incluant divers types de lymphomes, dont 128 patients atteints de lymphome folliculaire et 127 patients atteints de DLBCL en situation de rechute ou de maladie r\u00e9fractaire apr\u00e8s au moins deux traitements. Chez les patients atteints de lymphome folliculaire, environ 80 % ont r\u00e9pondu au traitement apr\u00e8s 52 semaines, avec 73 % (94\/128) de r\u00e9ponses compl\u00e8tes (absence de signes de cancer) et 7 % (9\/128) de r\u00e9ponses partielles. La dur\u00e9e moyenne de maintien de la r\u00e9ponse \u00e9tait de 23 mois. Chez les patients atteints de DLBCL, environ 52 % ont r\u00e9pondu, dont 31 % (40\/127) avec une r\u00e9ponse compl\u00e8te. Le traitement n\u2019a pas \u00e9t\u00e9 compar\u00e9 \u00e0 d\u2019autres options th\u00e9rapeutiques, ce qui constitue une limite importante \u00e0 l\u2019interpr\u00e9tation comparative de ces r\u00e9sultats.<\/p>\n<p>Les informations d\u00e9taill\u00e9es sur les modalit\u00e9s d\u2019utilisation, les effets ind\u00e9sirables et les pr\u00e9cautions figurent dans la notice destin\u00e9e aux patients et sont \u00e0 compl\u00e9ter par l\u2019avis du m\u00e9decin ou du pharmacien. Ces \u00e9l\u00e9ments sont susceptibles d\u2019int\u00e9resser les autorit\u00e9s sanitaires et de r\u00e9gulation pour le suivi des innovations th\u00e9rapeutiques en oncologie, notamment en mati\u00e8re de conditions de prescription, de s\u00e9curit\u00e9 d\u2019emploi et d\u2019organisation des soins en milieu sp\u00e9cialis\u00e9. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/ordspono\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Ordspono est un m\u00e9dicament anticanc\u00e9reux indiqu\u00e9 chez l\u2019adulte pour le traitement du lymphome folliculaire et du lymphome diffus \u00e0 grandes cellules B (DLBCL), deux formes de cancers du sang. Il [&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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[257,227,226],"class_list":["post-19711","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/19711","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=19711"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/19711\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=19711"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=19711"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=19711"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}