Le 17 septembre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a adopt\u00e9 un avis favorable recommandant une modification des conditions d\u2019autorisation de mise sur le march\u00e9 du m\u00e9dicament Pepaxti, dont le titulaire est Oncopeptides AB. Cette d\u00e9cision sera ensuite soumise \u00e0 la Commission europ\u00e9enne, qui doit statuer avant la mise \u00e0 jour officielle des conditions d\u2019autorisation et la publication de la nouvelle version du r\u00e9sum\u00e9 des caract\u00e9ristiques du produit (RCP) dans toutes les langues officielles de l\u2019Union europ\u00e9enne.<\/p>\n
L\u2019avis du CHMP porte sur une extension de l\u2019indication de Pepaxti. Le m\u00e9dicament est d\u00e9sormais recommand\u00e9, en association avec la dexam\u00e9thasone, pour le traitement des patients adultes atteints de my\u00e9lome multiple ayant re\u00e7u au moins deux lignes de traitement ant\u00e9rieures. Leur maladie doit \u00eatre r\u00e9fractaire \u00e0 au moins un inhibiteur du prot\u00e9asome, un agent immunomodulateur, un anticorps monoclonal anti-CD30 et \u00e0 la l\u00e9nalidomide, et avoir progress\u00e9 pendant ou apr\u00e8s la derni\u00e8re ligne de traitement. Pour les patients ayant d\u00e9j\u00e0 b\u00e9n\u00e9fici\u00e9 d\u2019une autogreffe de cellules souches, un d\u00e9lai minimal de trois ans entre la transplantation et la progression de la maladie est requis.<\/p>\n
Le m\u00e9dicament, r\u00e9f\u00e9renc\u00e9 sous le code EMEA\/H\/C\/005681, contient du melphalan flufenamide (code ATC L01AA10) et est indiqu\u00e9 dans le traitement du my\u00e9lome multiple. Les \u00e9l\u00e9ments d\u00e9taill\u00e9s d\u2019utilisation et de s\u00e9curit\u00e9 seront pr\u00e9cis\u00e9s dans le RCP actualis\u00e9 une fois la d\u00e9cision de la Commission europ\u00e9enne formellement adopt\u00e9e. Cette \u00e9volution s\u2019inscrit dans le cadre des travaux r\u00e9guliers du CHMP, d\u00e9j\u00e0 mentionn\u00e9 dans des comptes rendus de r\u00e9unions ant\u00e9rieures des 20-23 juin 2022 et 11-14 septembre 2023. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 17 septembre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a adopt\u00e9 un avis favorable recommandant une modification des conditions d\u2019autorisation de mise […]<\/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-18079","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\/18079","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=18079"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18079\/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=18079"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18079"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18079"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}