{"id":21442,"date":"2026-10-19T12:47:06","date_gmt":"2026-10-19T12:47:06","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21442"},"modified":"2026-10-19T12:47:06","modified_gmt":"2026-10-19T12:47:06","slug":"rapport-europeen-public-devaluation-pour-les-medicaments-a-usage-humain-epar-vizimpro-dacomitinib-date-dautorisation-02-04-2019-revision-4-statut-autorise-titre-t","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21442","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation pour les m\u00e9dicaments \u00e0 usage humain (EPAR) : Vizimpro, dacomitinib, Date d\u2019autorisation : 02\/04\/2019, R\u00e9vision : 4, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Vizimpro est un m\u00e9dicament anticanc\u00e9reux autoris\u00e9 dans l\u2019Union europ\u00e9enne pour le traitement des adultes atteints de cancer du poumon non \u00e0 petites cellules (CPNPC) \u00e0 un stade avanc\u00e9 ou m\u00e9tastatique. Il est indiqu\u00e9 en monoth\u00e9rapie uniquement chez les patients pr\u00e9sentant certaines mutations du g\u00e8ne du r\u00e9cepteur du facteur de croissance \u00e9pidermique (EGFR), pr\u00e9alablement confirm\u00e9es par des tests appropri\u00e9s.<\/p>\n<p>Le principe actif de Vizimpro est le dacomitinib, un inhibiteur de tyrosine kinase qui bloque l\u2019activit\u00e9 d\u2019EGFR, prot\u00e9ine impliqu\u00e9e dans la croissance et la division cellulaires. Dans les cellules tumorales pulmonaires, EGFR est fr\u00e9quemment suractiv\u00e9, ce qui entra\u00eene une prolif\u00e9ration incontr\u00f4l\u00e9e. Le blocage de ce r\u00e9cepteur permet de r\u00e9duire la croissance et la propagation de la tumeur.<\/p>\n<p>Vizimpro est disponible sous forme de comprim\u00e9s dos\u00e9s \u00e0 15, 30 et 45 mg. La posologie habituelle est de 45 mg une fois par jour, \u00e0 heure fixe, poursuivie tant que le traitement est b\u00e9n\u00e9fique et que les effets ind\u00e9sirables restent tol\u00e9rables. En cas de survenue de certains effets ind\u00e9sirables, une r\u00e9duction de dose ou un arr\u00eat du traitement peut \u00eatre d\u00e9cid\u00e9e par le m\u00e9decin. Le m\u00e9dicament est soumis \u00e0 prescription m\u00e9dicale et son initiation ainsi que son suivi doivent \u00eatre assur\u00e9s par un m\u00e9decin exp\u00e9riment\u00e9 dans l\u2019utilisation des traitements anticanc\u00e9reux.<\/p>\n<p>Les donn\u00e9es cliniques pr\u00e9sent\u00e9es \u00e0 l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) reposent notamment sur une \u00e9tude principale incluant 452 patients porteurs de mutations EGFR. Dans cette \u00e9tude, Vizimpro a \u00e9t\u00e9 compar\u00e9 au g\u00e9fitinib, un autre traitement du CPNPC. Les patients trait\u00e9s par Vizimpro ont v\u00e9cu en moyenne environ 15 mois sans progression de la maladie, contre 9 mois pour ceux recevant du g\u00e9fitinib, soit un gain d\u2019environ 6 mois de survie sans progression.<\/p>\n<p>Les effets ind\u00e9sirables les plus fr\u00e9quents (touchant plus d\u2019un patient sur cinq) comprennent diarrh\u00e9e, \u00e9ruption cutan\u00e9e, stomatite, troubles des ongles, s\u00e9cheresse cutan\u00e9e, perte d\u2019app\u00e9tit, conjonctivite, perte de poids et de cheveux, prurit, \u00e9l\u00e9vation des transaminases h\u00e9patiques et naus\u00e9es. Les effets ind\u00e9sirables graves les plus fr\u00e9quents sont la diarrh\u00e9e, les maladies pulmonaires interstitielles, l\u2019\u00e9ruption cutan\u00e9e et la perte d\u2019app\u00e9tit. La liste compl\u00e8te des effets ind\u00e9sirables et des restrictions figure dans la notice du m\u00e9dicament.<\/p>\n<p>L\u2019EMA a conclu que, malgr\u00e9 une fr\u00e9quence plus \u00e9lev\u00e9e d\u2019effets ind\u00e9sirables par rapport au g\u00e9fitinib, ceux-ci demeuraient g\u00e9rables et que le b\u00e9n\u00e9fice de Vizimpro en termes de survie sans progression justifiait son autorisation de mise sur le march\u00e9 dans l\u2019UE. Cette d\u00e9cision s\u2019inscrit dans le cadre de la r\u00e9gulation europ\u00e9enne des m\u00e9dicaments et constitue une information de r\u00e9f\u00e9rence pour le suivi des politiques de sant\u00e9, en particulier en mati\u00e8re d\u2019acc\u00e8s \u00e0 l\u2019innovation th\u00e9rapeutique en oncologie et de prise en charge cibl\u00e9e des cancers en fonction de profils g\u00e9n\u00e9tiques sp\u00e9cifiques. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/vizimpro\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Vizimpro est un m\u00e9dicament anticanc\u00e9reux autoris\u00e9 dans l\u2019Union europ\u00e9enne pour le traitement des adultes atteints de cancer du poumon non \u00e0 petites cellules (CPNPC) \u00e0 un stade avanc\u00e9 ou m\u00e9tastatique. [&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-21442","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\/21442","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=21442"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21442\/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=21442"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21442"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21442"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}