La d\u00e9cision pr\u00e9sent\u00e9e \u00e9tablit un cadre de prescription compassionnelle (CPC) pour les m\u00e9dicaments Voranigo 10 mg et Voranigo 40 mg, comprim\u00e9s pellicul\u00e9s. Ce cadre concerne la France et rel\u00e8ve de l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM), dont la directrice g\u00e9n\u00e9rale est \u00e0 l\u2019origine de la d\u00e9cision.<\/p>\n
Le CPC s\u2019applique \u00e0 l\u2019utilisation de Voranigo en monoth\u00e9rapie pour le traitement des gliomes de bas grade (astrocytomes ou oligodendrogliomes) pr\u00e9sentant une mutation IDH1 R132 ou IDH2 R172, chez des patients adultes pesant au moins 40 kg. Les patients concern\u00e9s doivent \u00eatre inop\u00e9rables, ou non r\u00e9pondeurs, ou en progression apr\u00e8s une radioth\u00e9rapie et\/ou au moins une ligne de chimioth\u00e9rapie syst\u00e9mique, ou encore intol\u00e9rants \u00e0 la radioth\u00e9rapie et\/ou \u00e0 la chimioth\u00e9rapie.<\/p>\n
La d\u00e9cision se fonde sur le code de la sant\u00e9 publique (articles L. 5121-12-1 III, L. 5121-14-3 et R. 5121-76-1 \u00e0 R. 5121-76-11). Elle intervient \u00e0 la suite d\u2019une d\u00e9marche formalis\u00e9e : l\u2019ANSM a notifi\u00e9, par courrier du 8 septembre 2026 envoy\u00e9 par courriel le 9 septembre 2026, son intention d\u2019\u00e9tablir ce CPC aux laboratoires Servier, en leur transmettant un projet de d\u00e9cision et un projet de protocole d\u2019utilisation th\u00e9rapeutique et de suivi des patients (PUT-SP) pour observations. Les observations de l\u2019entreprise ont \u00e9t\u00e9 re\u00e7ues le 1er octobre 2026.<\/p>\n
L\u2019entreprise exploitant Voranigo est responsable de la mise en \u0153uvre du CPC, conform\u00e9ment au protocole d\u2019utilisation th\u00e9rapeutique et de suivi des patients annex\u00e9 \u00e0 la d\u00e9cision. Le suivi national de pharmacovigilance dans le cadre de ce dispositif est confi\u00e9 au Centre r\u00e9gional de pharmacovigilance (CRPV) de Rouen.<\/p>\n
Les entreprises exploitant les m\u00e9dicaments couverts par le CPC doivent transmettre \u00e0 l\u2019ANSM, par voie d\u00e9mat\u00e9rialis\u00e9e, ainsi qu\u2019au CRPV de Rouen, des rapports p\u00e9riodiques de synth\u00e8se des donn\u00e9es, selon la p\u00e9riodicit\u00e9 et les modalit\u00e9s pr\u00e9cis\u00e9es dans le protocole de suivi, conform\u00e9ment \u00e0 l\u2019article R. 5121-76-6 du code de la sant\u00e9 publique. Une analyse finale de l\u2019ensemble des donn\u00e9es recueillies pendant la dur\u00e9e du CPC doit \u00eatre adress\u00e9e \u00e0 l\u2019ANSM dans un d\u00e9lai de six mois apr\u00e8s la fin du dispositif.\u00a0(contenu r\u00e9sum\u00e9 par l’IA)Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":" La d\u00e9cision pr\u00e9sent\u00e9e \u00e9tablit un cadre de prescription compassionnelle (CPC) pour les m\u00e9dicaments Voranigo 10 mg et Voranigo 40 mg, comprim\u00e9s pellicul\u00e9s. Ce cadre concerne la France et rel\u00e8ve de […]<\/p>\n","protected":false},"author":1,"featured_media":3852,"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":[63,227],"class_list":["post-21724","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ansm","tag-ia"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21724","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=21724"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21724\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/3852"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21724"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21724"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21724"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}