{"id":21552,"date":"2026-10-20T10:49:16","date_gmt":"2026-10-20T10:49:16","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21552"},"modified":"2026-10-20T10:49:16","modified_gmt":"2026-10-20T10:49:16","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-xofigo-radium-ra223-dichlorure-date-dautorisation-13-11-2013-revision-17-statut-autorise","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21552","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Xofigo, radium Ra223 dichlorure, Date d\u2019autorisation : 13\/11\/2013, R\u00e9vision : 17, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Xofigo est un m\u00e9dicament radiopharmaceutique destin\u00e9 au traitement des adultes atteints d\u2019un cancer de la prostate r\u00e9sistant \u00e0 la castration (chirurgicale ou m\u00e9dicamenteuse), lorsque la maladie s\u2019est propag\u00e9e aux os (m\u00e9tastases osseuses) avec sympt\u00f4mes, notamment douloureux, sans atteinte d\u2019autres organes internes. Il est r\u00e9serv\u00e9 aux patients ayant d\u00e9j\u00e0 re\u00e7u au moins deux traitements ant\u00e9rieurs contre le cancer de la prostate ou ne pouvant pas b\u00e9n\u00e9ficier d\u2019autres options th\u00e9rapeutiques. Xofigo peut \u00eatre utilis\u00e9 seul ou en association avec un analogue de la LHRH. Il contient du dichlorure de radium\u2011223 comme substance active.<\/p>\n<p>Le m\u00e9dicament ne peut \u00eatre d\u00e9livr\u00e9 que sur prescription et doit \u00eatre manipul\u00e9 et administr\u00e9 uniquement par des professionnels habilit\u00e9s \u00e0 utiliser des m\u00e9dicaments radioactifs, apr\u00e8s \u00e9valuation du patient par un m\u00e9decin qualifi\u00e9. La dose est calcul\u00e9e en fonction du poids corporel afin d\u2019atteindre un niveau d\u00e9termin\u00e9 de radioactivit\u00e9. L\u2019administration se fait par injection intraveineuse lente (jusqu\u2019\u00e0 une minute), r\u00e9p\u00e9t\u00e9e toutes les quatre semaines, pour un total de six injections.<\/p>\n<p>Le radium\u2011223 se fixe sur l\u2019os de la m\u00eame mani\u00e8re que le calcium et s\u2019accumule dans les zones osseuses envahies par les cellules canc\u00e9reuses. Il \u00e9met des particules alpha de courte port\u00e9e qui d\u00e9truisent les cellules tumorales \u00e0 proximit\u00e9 et contribuent au contr\u00f4le des sympt\u00f4mes associ\u00e9s.<\/p>\n<p>L\u2019efficacit\u00e9 de Xofigo a \u00e9t\u00e9 \u00e9valu\u00e9e dans une \u00e9tude principale portant sur 921 hommes atteints d\u2019un cancer de la prostate m\u00e9tastas\u00e9 aux os, non contr\u00f4l\u00e9 par la suppression hormonale. Les patients recevaient jusqu\u2019\u00e0 six injections \u00e0 un mois d\u2019intervalle et \u00e9taient suivis pendant trois ans \u00e0 partir de la premi\u00e8re injection. En moyenne, la survie globale \u00e9tait de 14,9 mois avec Xofigo, contre 11,3 mois avec un placebo administr\u00e9 en plus des soins standards. Les signes et sympt\u00f4mes de progression, notamment la douleur osseuse, apparaissaient plus tardivement chez les patients trait\u00e9s par Xofigo.<\/p>\n<p>Les effets ind\u00e9sirables les plus fr\u00e9quents (plus de 1 patient sur 10) sont la diarrh\u00e9e, les naus\u00e9es, les vomissements, la thrombocytop\u00e9nie (diminution des plaquettes sanguines) et les fractures osseuses. Les effets ind\u00e9sirables les plus graves observ\u00e9s sont la thrombocytop\u00e9nie et la neutrop\u00e9nie (baisse des neutrophiles, globules blancs impliqu\u00e9s dans la lutte contre l\u2019infection). Xofigo ne doit pas \u00eatre utilis\u00e9 en association avec l\u2019abirat\u00e9rone ac\u00e9tate et les cortico\u00efdes prednisone ou prednisolone. Les autres restrictions et le d\u00e9tail des effets ind\u00e9sirables figurent dans la notice.<\/p>\n<p>L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a estim\u00e9 que le rapport b\u00e9n\u00e9fice\u2011risque de Xofigo \u00e9tait favorable et a autoris\u00e9 son utilisation dans l\u2019Union europ\u00e9enne. Les donn\u00e9es disponibles montrent notamment un allongement de la survie globale et un retard de la progression symptomatique chez les patients trait\u00e9s, sous r\u00e9serve du respect des conditions d\u2019utilisation et des contre\u2011indications, en particulier concernant les associations m\u00e9dicamenteuses. Ces \u00e9l\u00e9ments pr\u00e9sentent un int\u00e9r\u00eat pour le suivi des strat\u00e9gies th\u00e9rapeutiques du cancer de la prostate m\u00e9tastatique et des conditions de mise sur le march\u00e9 des m\u00e9dicaments radiopharmaceutiques au niveau europ\u00e9en. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/xofigo\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Xofigo est un m\u00e9dicament radiopharmaceutique destin\u00e9 au traitement des adultes atteints d\u2019un cancer de la prostate r\u00e9sistant \u00e0 la castration (chirurgicale ou m\u00e9dicamenteuse), lorsque la maladie s\u2019est propag\u00e9e aux os [&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-21552","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\/21552","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=21552"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21552\/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=21552"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21552"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21552"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}