Le 17 septembre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a \u00e9mis un avis favorable recommandant une modification des termes de l\u2019autorisation de mise sur le march\u00e9 du m\u00e9dicament Enhertu, dont le titulaire est Daiichi Sankyo Europe GmbH. La principale \u00e9volution concerne l\u2019ajout d\u2019une nouvelle indication en situation de cancer du sein pr\u00e9coce : Enhertu en monoth\u00e9rapie est d\u00e9sormais recommand\u00e9 en traitement adjuvant chez les patients adultes atteints d\u2019un cancer du sein HER2-positif r\u00e9s\u00e9qu\u00e9, pr\u00e9sentant une maladie invasive r\u00e9siduelle apr\u00e8s un traitement n\u00e9oadjuvant associant un taxane et une th\u00e9rapie ciblant HER2. La s\u00e9lection des patients sur la base de biomarqueurs est renvoy\u00e9e \u00e0 la rubrique 4.2 du r\u00e9sum\u00e9 des caract\u00e9ristiques du produit.<\/p>\n
L\u2019avis rappelle \u00e9galement l\u2019ensemble des indications d\u2019Enhertu. Pour le cancer du sein m\u00e9tastatique HER2-positif, Enhertu est indiqu\u00e9 : en association avec le pertuzumab en premi\u00e8re ligne chez les adultes atteints d\u2019un cancer du sein non r\u00e9s\u00e9cable ou m\u00e9tastatique, et en monoth\u00e9rapie chez les adultes d\u00e9j\u00e0 trait\u00e9s par une ou plusieurs lignes ant\u00e9rieures \u00e0 base d\u2019anti-HER2. Pour les cancers du sein HER2-low et HER2-ultralow, HR-positifs et non r\u00e9s\u00e9cables ou m\u00e9tastatiques, Enhertu en monoth\u00e9rapie est indiqu\u00e9 chez les adultes ayant re\u00e7u au moins un traitement endocrinien en phase m\u00e9tastatique et non \u00e9ligibles \u00e0 une nouvelle ligne d\u2019hormonoth\u00e9rapie, ainsi que chez les patients HER2-low ayant re\u00e7u une chimioth\u00e9rapie en situation m\u00e9tastatique ou ayant pr\u00e9sent\u00e9 une r\u00e9cidive pendant ou dans les six mois suivant une chimioth\u00e9rapie adjuvante.<\/p>\n
L\u2019avis couvre \u00e9galement d\u2019autres localisations tumorales : dans le cancer bronchique non \u00e0 petites cellules avanc\u00e9, Enhertu en monoth\u00e9rapie est indiqu\u00e9 chez l\u2019adulte dont la tumeur pr\u00e9sente une mutation activatrice de HER2 (ERBB2) et n\u00e9cessitant un traitement syst\u00e9mique apr\u00e8s une chimioth\u00e9rapie \u00e0 base de platine, avec ou sans immunoth\u00e9rapie. Dans le cancer gastrique ou de la jonction \u0153so-gastrique avanc\u00e9 HER2-positif, Enhertu en monoth\u00e9rapie est indiqu\u00e9 chez les adultes pr\u00e9alablement trait\u00e9s par un sch\u00e9ma \u00e0 base de trastuzumab. Enfin, Enhertu en monoth\u00e9rapie est indiqu\u00e9 dans le traitement des tumeurs solides HER2-positives (IHC3+) non r\u00e9s\u00e9cables ou m\u00e9tastatiques chez l\u2019adulte, apr\u00e8s au moins un traitement ant\u00e9rieur et en l\u2019absence d\u2019options th\u00e9rapeutiques satisfaisantes, sous r\u00e9serve d\u2019une s\u00e9lection des patients fond\u00e9e sur des biomarqueurs et des pr\u00e9cautions pr\u00e9cis\u00e9es aux rubriques 4.2, 4.4 et 5.1. Les recommandations d\u00e9taill\u00e9es d\u2019utilisation feront l\u2019objet d\u2019une mise \u00e0 jour du r\u00e9sum\u00e9 des caract\u00e9ristiques du produit. Ces \u00e9volutions pr\u00e9sentent un int\u00e9r\u00eat pour le suivi des options th\u00e9rapeutiques anticanc\u00e9reuses au niveau europ\u00e9en, avec des implications potentielles en mati\u00e8re d\u2019acc\u00e8s aux traitements et de prise en charge en oncologie dans les \u00c9tats membres. (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 \u00e9mis un avis favorable recommandant une modification des termes de l\u2019autorisation de […]<\/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-17913","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\/17913","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=17913"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17913\/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=17913"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17913"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17913"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}