{"id":20790,"date":"2026-10-13T15:07:12","date_gmt":"2026-10-13T15:07:12","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=20790"},"modified":"2026-10-13T15:07:12","modified_gmt":"2026-10-13T15:07:12","slug":"medicaments-a-usage-humain-rapport-europeen-public-devaluation-epar-imfinzi-durvalumab-date-dautorisation-21-09-2018-revision-28-statut-autorise-titre-traduit-en","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=20790","title":{"rendered":"M\u00e9dicaments \u00e0 usage humain, rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) : Imfinzi, durvalumab, date d\u2019autorisation : 21\/09\/2018, r\u00e9vision : 28, statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Le document pr\u00e9sente les indications cliniques d\u2019Imfinzi, un m\u00e9dicament anticanc\u00e9reux destin\u00e9 \u00e0 l\u2019adulte. Il est utilis\u00e9 dans plusieurs localisations tumorales, principalement des cancers thoraciques et digestifs, ainsi que certains cancers gyn\u00e9cologiques et urologiques, selon des crit\u00e8res pr\u00e9cis de stade, de statut mol\u00e9culaire et de traitements ant\u00e9rieurs.<\/p>\n<p>Pour le cancer du poumon non \u00e0 petites cellules (CPNPC), Imfinzi est indiqu\u00e9 dans trois situations : chez des patients dont le cancer est localement avanc\u00e9, non r\u00e9s\u00e9cable, non progressif apr\u00e8s une radiochimioth\u00e9rapie \u00e0 base de sels de platine, et dont la tumeur exprime la prot\u00e9ine PD\u2011L1 ; chez des patients pr\u00e9sentant un CPNPC m\u00e9tastatique, sans mutation des g\u00e8nes EGFR ni ALK ; chez des patients dont la tumeur est r\u00e9s\u00e9cable, \u00e0 haut risque de r\u00e9cidive, sans mutation EGFR ni r\u00e9arrangement ALK.<\/p>\n<p>Pour le cancer du poumon \u00e0 petites cellules (CPPC), Imfinzi est utilis\u00e9 chez des adultes atteints d\u2019une forme dite \u00ab \u00e0 un stade \u00e9tendu \u00bb (atteinte intrapulmonaire et\/ou m\u00e9tastatique) n\u2019ayant pas encore re\u00e7u de traitement, ainsi que dans la forme \u00ab \u00e0 un stade limit\u00e9 \u00bb (un seul poumon, tissus m\u00e9diastinaux et ganglions de voisinage), lorsque la maladie n\u2019a pas progress\u00e9 apr\u00e8s une chimioradioth\u00e9rapie \u00e0 base de platine.<\/p>\n<p>Imfinzi est \u00e9galement indiqu\u00e9 dans les cancers des voies biliaires (biliary tract cancer, BTC) chez l\u2019adulte en premi\u00e8re ligne de traitement lorsque la tumeur n\u2019est pas r\u00e9s\u00e9cable ou m\u00e9tastatique, et dans le carcinome h\u00e9patocellulaire (HCC) avanc\u00e9 ou non r\u00e9s\u00e9cable, en premi\u00e8re ligne \u00e9galement. Dans ces deux cas, il s\u2019agit de cancers digestifs de stade avanc\u00e9, pour lesquels la chirurgie n\u2019est pas possible ou plus possible.<\/p>\n<p>Dans le cancer de l\u2019endom\u00e8tre, Imfinzi s\u2019adresse \u00e0 des adultes pr\u00e9sentant une maladie avanc\u00e9e ou r\u00e9cidivante. Il est administr\u00e9 initialement en association avec la carboplatine et le paclitaxel. En traitement d\u2019entretien, deux sch\u00e9mas sont distingu\u00e9s selon le statut de r\u00e9paration des m\u00e9sappariements de l\u2019ADN : en monoth\u00e9rapie chez les patientes pr\u00e9sentant une tumeur \u00ab mismatch repair deficient \u00bb (dMMR), ou en association avec l\u2019olaparib chez celles pr\u00e9sentant une tumeur \u00ab mismatch repair proficient \u00bb (pMMR).<\/p>\n<p>Imfinzi est en outre indiqu\u00e9 chez l\u2019adulte atteint de cancer de la vessie musculoinvasif (MIBC) lorsque la tumeur est r\u00e9s\u00e9cable, c\u2019est\u2011\u00e0\u2011dire lorsque l\u2019atteinte d\u00e9passe la muqueuse et s\u2019\u00e9tend au muscle de la paroi v\u00e9sicale. Enfin, il est utilis\u00e9 dans l\u2019ad\u00e9nocarcinome gastrique ou de la jonction gastro\u2011\u0153sophagienne r\u00e9s\u00e9cable, chez l\u2019adulte. Selon l\u2019indication, le m\u00e9dicament peut \u00eatre administr\u00e9 seul ou en association avec une chimioth\u00e9rapie (ou, dans l\u2019endom\u00e8tre pMMR, avec un autre anticanc\u00e9reux cibl\u00e9).<\/p>\n<p>L\u2019ensemble de ces indications illustre une expansion d\u2019usage d\u2019un m\u00eame m\u00e9dicament en oncologie adulte sur plusieurs localisations et stades tumoraux, conditionn\u00e9e par des caract\u00e9ristiques cliniques (stade localement avanc\u00e9, m\u00e9tastatique, r\u00e9s\u00e9cable\/non r\u00e9s\u00e9cable, r\u00e9ponse \u00e0 des traitements ant\u00e9rieurs) et biologiques (expression PD\u2011L1, statut EGFR\/ALK, statut de r\u00e9paration des m\u00e9sappariements). Ces \u00e9l\u00e9ments sont susceptibles d\u2019avoir des cons\u00e9quences en mati\u00e8re de prise en charge th\u00e9rapeutique, d\u2019organisation des soins et de suivi des d\u00e9penses li\u00e9es \u00e0 l\u2019acc\u00e8s aux th\u00e9rapies innovantes en canc\u00e9rologie. Les autorit\u00e9s publiques mentionn\u00e9es implicitement sont les instances de r\u00e9gulation du m\u00e9dicament au niveau national ou europ\u00e9en, qui encadrent ces indications, mais le texte ne pr\u00e9cise ni pays, ni dates, ni d\u00e9cisions r\u00e9glementaires particuli\u00e8res. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/imfinzi\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Le document pr\u00e9sente les indications cliniques d\u2019Imfinzi, un m\u00e9dicament anticanc\u00e9reux destin\u00e9 \u00e0 l\u2019adulte. Il est utilis\u00e9 dans plusieurs localisations tumorales, principalement des cancers thoraciques et digestifs, ainsi que certains cancers [&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-20790","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\/20790","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=20790"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20790\/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=20790"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20790"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20790"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}