Le 2 juin 2026, l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a rendu un avis d\u00e9favorable \u00e0 la demande d\u2019autorisation d\u2019acc\u00e8s pr\u00e9coce (AAP) concernant le m\u00e9dicament Ibrance (palbociclib) en g\u00e9lules dos\u00e9es \u00e0 75 mg, 100 mg et 125 mg, d\u00e9pos\u00e9e par le laboratoire Pfizer. La demande initiale a \u00e9t\u00e9 d\u00e9pos\u00e9e le 16 janvier 2026 et compl\u00e9t\u00e9e les 28 janvier, 5 f\u00e9vrier et 7 mai 2026.<\/p>\n
L\u2019indication th\u00e9rapeutique demand\u00e9e portait sur l\u2019utilisation d\u2019Ibrance en association avec un traitement anti-HER2 et une hormonoth\u00e9rapie, en traitement d\u2019entretien chez des patients adultes atteints d\u2019un cancer du sein RH-positif, HER2 positif, localement avanc\u00e9 ou m\u00e9tastatique, apr\u00e8s un traitement d\u2019induction. Pour les femmes en pr\u00e9- ou p\u00e9rim\u00e9nopause, l\u2019hormonoth\u00e9rapie devait \u00eatre associ\u00e9e \u00e0 un agoniste de la LH-RH dans le cadre de ce cancer du sein HER2 positif.<\/p>\n
L\u2019ANSM indique ne pas pouvoir attester, en l\u2019\u00e9tat des donn\u00e9es disponibles, d\u2019une forte pr\u00e9somption d\u2019efficacit\u00e9 et de s\u00e9curit\u00e9 d\u2019Ibrance dans l\u2019indication revendiqu\u00e9e. L\u2019agence ne reconna\u00eet donc pas les conditions requises pour accorder l\u2019acc\u00e8s pr\u00e9coce dans ce contexte. La motivation scientifique d\u00e9taill\u00e9e de cette position est pr\u00e9sent\u00e9e en annexe de l\u2019avis, accessible via la fiche AAP d\u00e9di\u00e9e \u00e0 Ibrance. L\u2019avis est sign\u00e9 par le directeur Europe et Innovation de l\u2019ANSM, Pierre-Olivier Farenq.\u00a0(contenu r\u00e9sum\u00e9 par l’IA)Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":" Le 2 juin 2026, l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a rendu un avis d\u00e9favorable \u00e0 la demande d\u2019autorisation d\u2019acc\u00e8s pr\u00e9coce (AAP) concernant le […]<\/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-16159","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\/16159","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=16159"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/16159\/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=16159"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=16159"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=16159"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}