Le document pr\u00e9sente l\u2019\u00e9valuation r\u00e9alis\u00e9e au niveau europ\u00e9en par le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) concernant Iressa, un m\u00e9dicament anticanc\u00e9reux contenant du g\u00e9fitinib. Cette \u00e9valuation s\u2019inscrit dans le cadre du rapport public europ\u00e9en d\u2019\u00e9valuation (EPAR), qui pr\u00e9cise les conditions d\u2019utilisation du m\u00e9dicament dans l\u2019Union europ\u00e9enne.<\/p>\n
Iressa est indiqu\u00e9 chez l\u2019adulte pour le traitement du cancer bronchique non \u00e0 petites cellules (CBNPC) localement avanc\u00e9 ou m\u00e9tastatique, lorsque les cellules tumorales pr\u00e9sentent une mutation du g\u00e8ne codant le r\u00e9cepteur du facteur de croissance \u00e9pidermique (EGFR). Le traitement doit \u00eatre initi\u00e9 et surveill\u00e9 par un m\u00e9decin exp\u00e9riment\u00e9 en oncologie. La posologie recommand\u00e9e est d\u2019un comprim\u00e9 de 250 mg une fois par jour, avec possibilit\u00e9 de dispersion dans l\u2019eau chez les patients ayant des difficult\u00e9s de d\u00e9glutition.<\/p>\n
Le m\u00e9canisme d\u2019action repose sur l\u2019inhibition des tyrosine kinases, en particulier au niveau du r\u00e9cepteur EGFR pr\u00e9sent \u00e0 la surface des cellules de CBNPC. En bloquant ce r\u00e9cepteur impliqu\u00e9 dans la croissance et la diss\u00e9mination des cellules canc\u00e9reuses, Iressa ralentit la progression tumorale. Le m\u00e9dicament n\u2019est actif que chez les patients dont les cellules tumorales pr\u00e9sentent une mutation de l\u2019EGFR.<\/p>\n
L\u2019efficacit\u00e9 d\u2019Iressa a \u00e9t\u00e9 \u00e9valu\u00e9e dans deux \u00e9tudes principales portant sur des adultes atteints de CBNPC localement avanc\u00e9 ou m\u00e9tastatique, incluant des patients avec et sans mutation de l\u2019EGFR. Dans la premi\u00e8re \u00e9tude (1 217 patients), Iressa a \u00e9t\u00e9 compar\u00e9 \u00e0 une association carboplatine\u2013paclitaxel. Le crit\u00e8re principal \u00e9tait la dur\u00e9e de survie sans progression. Chez les patients porteurs d\u2019une mutation de l\u2019EGFR, la dur\u00e9e moyenne sans aggravation de la maladie a \u00e9t\u00e9 d\u2019environ 9,5 mois sous Iressa, contre environ 6 mois sous la th\u00e9rapie combin\u00e9e. Dans la deuxi\u00e8me \u00e9tude (1 466 patients), Iressa a \u00e9t\u00e9 compar\u00e9 au doc\u00e9taxel, avec pour crit\u00e8re principal la survie globale. La survie des patients trait\u00e9s par Iressa \u00e9tait similaire \u00e0 celle des patients recevant le doc\u00e9taxel dans l\u2019ensemble de la population \u00e9tudi\u00e9e.<\/p>\n
Les effets ind\u00e9sirables les plus fr\u00e9quents (touchant plus d\u2019un patient sur dix) incluent notamment une perte d\u2019app\u00e9tit et des diarrh\u00e9es. Le document renvoie, pour des informations plus d\u00e9taill\u00e9es sur la pathologie, le traitement, les effets ind\u00e9sirables et les modalit\u00e9s pratiques, \u00e0 la notice destin\u00e9e aux patients ainsi qu\u2019\u00e0 la discussion scientifique, qui font \u00e9galement partie de l\u2019EPAR. Le r\u00f4le du CHMP est ici de centraliser et d\u2019analyser les donn\u00e9es cliniques issues des \u00e9tudes pour formuler des recommandations sur l\u2019usage du m\u00e9dicament dans l\u2019UE, constituant un \u00e9l\u00e9ment de r\u00e9f\u00e9rence pour les autorit\u00e9s nationales comp\u00e9tentes en mati\u00e8re de m\u00e9dicaments et de politique de sant\u00e9. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document pr\u00e9sente l\u2019\u00e9valuation r\u00e9alis\u00e9e au niveau europ\u00e9en par le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) concernant Iressa, un m\u00e9dicament anticanc\u00e9reux contenant du g\u00e9fitinib. Cette \u00e9valuation s\u2019inscrit dans le […]<\/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-21443","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\/21443","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=21443"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21443\/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=21443"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21443"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21443"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}