{"id":21553,"date":"2026-10-20T10:49:16","date_gmt":"2026-10-20T10:49:16","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21553"},"modified":"2026-10-20T10:49:16","modified_gmt":"2026-10-20T10:49:16","slug":"rapport-europeen-public-devaluation-epar-des-medicaments-a-usage-humain-tookad-padeliporfine-date-dautorisation-11-10-2017-revision-6-statut-autorise-titre-tradui","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21553","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) des m\u00e9dicaments \u00e0 usage humain : Tookad, pad\u00e9liporfine, Date d\u2019autorisation : 11\/10\/2017, R\u00e9vision : 6, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a \u00e9valu\u00e9 le m\u00e9dicament Tookad en vue de son autorisation dans l\u2019Union europ\u00e9enne et a d\u00e9fini ses conditions d\u2019utilisation. Tookad est indiqu\u00e9 chez les hommes pr\u00e9sentant un cancer de la prostate \u00e0 faible risque, localis\u00e9 \u00e0 un seul lobe de la prostate, avec une esp\u00e9rance de vie d\u2019au moins dix ans. Il contient comme substance active le padeliporfin et n\u2019est disponible que sur prescription, en milieu hospitalier, entre les mains de professionnels de sant\u00e9 sp\u00e9cifiquement form\u00e9s.<\/p>\n<p>Le traitement repose sur une technique de th\u00e9rapie photodynamique vasculaire (VTP). Tookad est administr\u00e9 par perfusion intraveineuse de 10 minutes, puis activ\u00e9 au niveau de la prostate par une lumi\u00e8re laser. Sous anesth\u00e9sie g\u00e9n\u00e9rale, des fibres optiques sont introduites dans la prostate \u00e0 l\u2019aide d\u2019aiguilles creuses afin de d\u00e9livrer la lumi\u00e8re sur la zone tumorale. Une fois activ\u00e9, le padeliporfin induit la formation de radicaux oxyg\u00e9n\u00e9s qui d\u00e9truisent les vaisseaux sanguins alimentant la tumeur, entra\u00eenant la mort rapide des cellules canc\u00e9reuses.<\/p>\n<p>Les donn\u00e9es d\u2019efficacit\u00e9 proviennent notamment d\u2019une \u00e9tude portant sur 413 hommes atteints d\u2019un cancer de la prostate \u00e0 faible risque. Apr\u00e8s 24 mois, 49 % des patients trait\u00e9s par Tookad-VTP ne pr\u00e9sentaient plus de signes histologiques de cancer, contre 14 % dans le groupe sans traitement. Le traitement a \u00e9galement retard\u00e9 la progression vers une forme de risque plus \u00e9lev\u00e9 : la progression survenait en moyenne apr\u00e8s 28 mois chez les patients trait\u00e9s par Tookad, contre 14 mois chez ceux n\u2019ayant pas re\u00e7u de traitement.<\/p>\n<p>Les effets ind\u00e9sirables les plus fr\u00e9quents (jusqu\u2019\u00e0 un patient sur quatre) sont des troubles urinaires (douleurs, r\u00e9tention, envies imp\u00e9rieuses, pollakiurie, incontinence), des troubles sexuels (dysfonction \u00e9rectile, troubles de l\u2019\u00e9jaculation), une h\u00e9maturie, des infections urinaires et des douleurs ou saignements au niveau de la r\u00e9gion g\u00e9nitale. D\u2019autres effets sont li\u00e9s \u00e0 l\u2019anesth\u00e9sie g\u00e9n\u00e9rale (troubles transitoires de la m\u00e9moire, anomalies du rythme cardiaque) et \u00e0 des atteintes h\u00e9patiques l\u00e9g\u00e8res (augmentation des enzymes h\u00e9patiques). Tookad est contre-indiqu\u00e9 chez les hommes ayant subi certaines interventions sur la prostate, ceux pr\u00e9sentant une cholestase, une pouss\u00e9e de maladie inflammatoire chronique de l\u2019intestin ou une contre-indication \u00e0 l\u2019anesth\u00e9sie g\u00e9n\u00e9rale ou \u00e0 ce type de proc\u00e9dure invasive. Les informations d\u00e9taill\u00e9es sur les effets ind\u00e9sirables, contre-indications et modalit\u00e9s pratiques figurent dans la notice destin\u00e9e aux patients. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/tookad\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a \u00e9valu\u00e9 le m\u00e9dicament Tookad en vue de son autorisation dans l\u2019Union europ\u00e9enne et a d\u00e9fini ses conditions d\u2019utilisation. Tookad est indiqu\u00e9 chez les hommes [&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-21553","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\/21553","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=21553"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21553\/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=21553"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21553"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21553"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}