Le 15 octobre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a adopt\u00e9 un avis favorable recommandant l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9 pour Kizfizo, un m\u00e9dicament destin\u00e9 au traitement des tumeurs c\u00e9r\u00e9brales malignes. Ce m\u00e9dicament est indiqu\u00e9 chez l\u2019adulte atteint de glioblastome multiforme nouvellement diagnostiqu\u00e9, en association \u00e0 la radioth\u00e9rapie puis en monoth\u00e9rapie, ainsi que chez l\u2019enfant \u00e0 partir de 1 an, l\u2019adolescent et l\u2019adulte pr\u00e9sentant un gliome malin (glioblastome multiforme ou astrocytome anaplasique) en r\u00e9cidive ou en progression apr\u00e8s un traitement standard. Le demandeur est le laboratoire Orphelia Pharma.<\/p>\n
Kizfizo sera disponible sous forme de suspension orale \u00e0 40 mg\/ml. Sa substance active est le t\u00e9mozolomide, agent antin\u00e9oplasique alkylant (code ATC L01AX03) qui exerce un effet cytotoxique par alt\u00e9ration de l\u2019ADN apr\u00e8s conversion in vivo en diazom\u00e9thane. Les b\u00e9n\u00e9fices d\u00e9montr\u00e9s incluent une am\u00e9lioration de la survie globale chez les adultes avec glioblastome multiforme nouvellement diagnostiqu\u00e9 lorsqu\u2019il est utilis\u00e9 en association \u00e0 la radioth\u00e9rapie par rapport \u00e0 la radioth\u00e9rapie seule, ainsi qu\u2019une augmentation de la survie sans progression chez les patients p\u00e9diatriques et adultes atteints de gliome malin r\u00e9cidivant ou progressif, comparativement \u00e0 la procarbazine. Les effets ind\u00e9sirables les plus fr\u00e9quents rapport\u00e9s sont notamment naus\u00e9es, vomissements, constipation, diarrh\u00e9e, anorexie, c\u00e9phal\u00e9es, fatigue, convulsions, h\u00e9mipar\u00e9sie, aphasie\/dysphasie, alop\u00e9cie et \u00e9ruption cutan\u00e9e.<\/p>\n
Kizfizo est un m\u00e9dicament hybride de Temodal, autoris\u00e9 dans l\u2019Union europ\u00e9enne depuis le 26 janvier 1999. Il contient la m\u00eame substance active mais sous une forme gal\u00e9nique diff\u00e9rente (suspension orale \u00e0 40 mg\/ml) et couvre \u00e9galement le traitement des patients p\u00e9diatriques de 1 \u00e0 moins de 3 ans, \u00e9largissant ainsi le champ d\u2019utilisation par rapport au produit de r\u00e9f\u00e9rence. Des \u00e9tudes ont montr\u00e9 une qualit\u00e9 pharmaceutique satisfaisante et la bio\u00e9quivalence de Kizfizo par rapport \u00e0 Temodal. Le m\u00e9dicament doit \u00eatre prescrit par des m\u00e9decins exp\u00e9riment\u00e9s dans le traitement des tumeurs c\u00e9r\u00e9brales. Les recommandations d\u00e9taill\u00e9es d\u2019utilisation figureront dans le r\u00e9sum\u00e9 des caract\u00e9ristiques du produit (RCP), publi\u00e9 par l\u2019EMA dans toutes les langues officielles de l\u2019UE apr\u00e8s la d\u00e9cision formelle de la Commission europ\u00e9enne.<\/p>\n
Kizfizo a b\u00e9n\u00e9fici\u00e9 d\u2019une d\u00e9signation de m\u00e9dicament orphelin au cours de son d\u00e9veloppement. L\u2019EMA examinera \u00e0 pr\u00e9sent les donn\u00e9es disponibles pour d\u00e9terminer si cette d\u00e9signation peut \u00eatre maintenue. La proc\u00e9dure d\u2019autorisation repose sur le r\u00e9gime des m\u00e9dicaments hybrides, qui s\u2019appuie \u00e0 la fois sur les donn\u00e9es pr\u00e9cliniques et cliniques du m\u00e9dicament de r\u00e9f\u00e9rence et sur de nouvelles donn\u00e9es propres au produit. Ces \u00e9l\u00e9ments pr\u00e9sentent un int\u00e9r\u00eat pour le suivi des politiques pharmaceutiques europ\u00e9ennes et des traitements innovants disponibles pour les tumeurs c\u00e9r\u00e9brales rares et graves, incluant une population p\u00e9diatrique \u00e0 partir d\u2019un an. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 15 octobre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a adopt\u00e9 un avis favorable recommandant l\u2019octroi d\u2019une autorisation de mise sur […]<\/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-21270","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\/21270","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=21270"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21270\/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=21270"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21270"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21270"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}