{"id":21554,"date":"2026-10-20T10:49:16","date_gmt":"2026-10-20T10:49:16","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21554"},"modified":"2026-10-20T10:49:16","modified_gmt":"2026-10-20T10:49:16","slug":"rapport-europeen-public-devaluation-des-medicaments-a-usage-humain-epar-firmagon-degarelix-date-dautorisation-17-02-2009-revision-19-statut-autorise-titre-traduit","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21554","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation des m\u00e9dicaments \u00e0 usage humain (EPAR) : Firmagon, d\u00e9gar\u00e9lix, Date d\u2019autorisation : 17\/02\/2009, R\u00e9vision : 19, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Firmagon est un m\u00e9dicament indiqu\u00e9 chez l\u2019homme adulte dans le traitement du cancer de la prostate hormono-d\u00e9pendant. Il est utilis\u00e9, d\u2019une part, dans les formes avanc\u00e9es, lorsque la tumeur s\u2019est \u00e9tendue au-del\u00e0 du pelvis vers des tissus proches (ganglions lymphatiques, os), et, d\u2019autre part, avant ou en association \u00e0 une radioth\u00e9rapie dans les cancers de la prostate hormono-d\u00e9pendants localis\u00e9s \u00e0 haut risque ou localement avanc\u00e9s, lorsque le risque de progression locale est \u00e9lev\u00e9. La substance active est le d\u00e9gar\u00e9lix.<\/p>\n<p>Le traitement se fait par injection sous-cutan\u00e9e au niveau de l\u2019abdomen, avec un sch\u00e9ma d\u00e9butant par deux injections de 120 mg, suivies d\u2019une injection mensuelle de 80 mg. L\u2019efficacit\u00e9 est surveill\u00e9e par la mesure sanguine de la testost\u00e9rone et de l\u2019antig\u00e8ne sp\u00e9cifique de la prostate (PSA), marqueur fr\u00e9quemment \u00e9lev\u00e9 chez les hommes atteints de cancer de la prostate. Le m\u00e9dicament est soumis \u00e0 prescription m\u00e9dicale, son usage devant \u00eatre encadr\u00e9 par un m\u00e9decin ou un pharmacien, en s\u2019appuyant notamment sur la notice.<\/p>\n<p>Sur le plan pharmacologique, le d\u00e9gar\u00e9lix r\u00e9duit la production de testost\u00e9rone en bloquant l\u2019action de l\u2019hormone naturelle gonadolib\u00e9rine (GnRH), premi\u00e8re \u00e9tape de la cha\u00eene de production de testost\u00e9rone. En diminuant ainsi la testost\u00e9rone, il ralentit la croissance des cellules canc\u00e9reuses prostatiques. Apr\u00e8s injection, Firmagon forme un gel sous la peau qui lib\u00e8re progressivement la substance active sur plusieurs semaines.<\/p>\n<p>Les donn\u00e9es cliniques reposent principalement sur deux \u00e9tudes. Une \u00e9tude de phase avanc\u00e9e portant sur 610 hommes atteints de cancer de la prostate \u00e0 tous les stades a montr\u00e9 que Firmagon abaisse les taux de testost\u00e9rone \u00e0 des niveaux comparables \u00e0 ceux observ\u00e9s apr\u00e8s castration chirurgicale. Dans cette \u00e9tude comparative, Firmagon s\u2019est r\u00e9v\u00e9l\u00e9 aussi efficace que le leupror\u00e9line, autre traitement de r\u00e9f\u00e9rence du cancer de la prostate : sur la premi\u00e8re ann\u00e9e de traitement, 97 % des patients recevant Firmagon \u00e0 la posologie autoris\u00e9e (80 mg une fois par mois) ont pr\u00e9sent\u00e9 un taux de testost\u00e9rone inf\u00e9rieur au seuil requis, contre 96 % avec le leupror\u00e9line. Une seconde \u00e9tude portant sur 244 hommes atteints d\u2019un cancer de la prostate \u00e0 risque interm\u00e9diaire ou \u00e9lev\u00e9 a montr\u00e9 que Firmagon est aussi efficace que l\u2019association gos\u00e9r\u00e9line + bicalutamide pour r\u00e9duire le volume prostatique avant radioth\u00e9rapie : apr\u00e8s 12 semaines de traitement, la r\u00e9duction de volume prostatique \u00e9tait de 36,0 % sous Firmagon et de 35,3 % sous gos\u00e9r\u00e9line + bicalutamide.<\/p>\n<p>Les effets ind\u00e9sirables les plus fr\u00e9quents (plus d\u2019une personne sur dix) sont les bouff\u00e9es de chaleur et les r\u00e9actions au site d\u2019injection (notamment douleur et rougeur). La liste compl\u00e8te des effets ind\u00e9sirables et des restrictions d\u2019utilisation est disponible dans la documentation officielle du m\u00e9dicament. Ces \u00e9l\u00e9ments sont susceptibles d\u2019int\u00e9resser les autorit\u00e9s sanitaires et les d\u00e9cideurs en charge de la politique du m\u00e9dicament et de l\u2019organisation de la prise en charge des cancers de la prostate, notamment pour le suivi de l\u2019usage des analogues ou antagonistes de la GnRH, l\u2019\u00e9valuation de leur efficacit\u00e9 comparative et la surveillance de leurs effets ind\u00e9sirables. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/firmagon\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Firmagon est un m\u00e9dicament indiqu\u00e9 chez l\u2019homme adulte dans le traitement du cancer de la prostate hormono-d\u00e9pendant. Il est utilis\u00e9, d\u2019une part, dans les formes avanc\u00e9es, lorsque la tumeur s\u2019est [&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-21554","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\/21554","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=21554"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21554\/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=21554"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21554"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21554"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}