{"id":20450,"date":"2026-10-09T14:20:27","date_gmt":"2026-10-09T14:20:27","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=20450"},"modified":"2026-10-09T14:20:27","modified_gmt":"2026-10-09T14:20:27","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-pylclari-piflufolastat-18f-date-dautorisation-27-11-2023-revision-9-statut-autorise","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=20450","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Pylclari, piflufolastat (18F), Date d\u2019autorisation : 27\/11\/2023, R\u00e9vision : 9, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Le document pr\u00e9sente Pylclari, m\u00e9dicament de diagnostic \u00e0 base de piflufolastat (18F) destin\u00e9 aux adultes atteints de cancer de la prostate. Il est utilis\u00e9 en tomographie par \u00e9mission de positons (TEP) pour visualiser les cellules tumorales exprimant l\u2019antig\u00e8ne membranaire sp\u00e9cifique de la prostate (PSMA). Deux indications principales sont d\u00e9crites : la d\u00e9tection d\u2019une extension du cancer de la prostate aux ganglions lymphatiques ou \u00e0 d\u2019autres tissus avant le d\u00e9but du traitement, et la d\u00e9tection d\u2019une r\u00e9cidive chez des patients pr\u00e9sentant une \u00e9l\u00e9vation du taux sanguin d\u2019antig\u00e8ne prostatique sp\u00e9cifique (PSA) apr\u00e8s un traitement ant\u00e9rieur.<\/p>\n<p>Pylclari doit \u00eatre administr\u00e9 exclusivement dans un service de m\u00e9decine nucl\u00e9aire par des professionnels de sant\u00e9 form\u00e9s \u00e0 l\u2019utilisation et \u00e0 la manipulation des traceurs d\u2019imagerie nucl\u00e9aire. Le produit est inject\u00e9 par voie intraveineuse, suivie d\u2019un examen TEP. Le piflufolastat (18F) se fixe sp\u00e9cifiquement sur le PSMA, fortement exprim\u00e9 \u00e0 la surface de la majorit\u00e9 des cellules du cancer de la prostate. La pr\u00e9sence de fluor 18 radioactif permet la d\u00e9tection des zones d\u2019absorption du produit lors de l\u2019examen TEP, ce qui renseigne les m\u00e9decins sur la localisation des cellules tumorales. Le produit a un usage exclusivement diagnostique et ne traite pas le cancer.<\/p>\n<p>L\u2019efficacit\u00e9 de Pylclari repose sur trois \u00e9tudes principales. Dans une premi\u00e8re \u00e9tude, men\u00e9e chez 385 hommes atteints de cancer de la prostate, tous les patients ont re\u00e7u Pylclari et ont b\u00e9n\u00e9fici\u00e9 d\u2019un TEP. Apr\u00e8s lecture des images par trois m\u00e9decins, les patients \u00e0 haut risque ont \u00e9t\u00e9 op\u00e9r\u00e9s (prostatectomie). Parmi les 252 patients op\u00e9r\u00e9s, l\u2019examen TEP a correctement identifi\u00e9 l\u2019absence de cellules canc\u00e9reuses dans certaines parties de la prostate chez plus de 96 % des patients. Une deuxi\u00e8me \u00e9tude a port\u00e9 sur 208 hommes chez lesquels une r\u00e9cidive de cancer de la prostate \u00e9tait suspect\u00e9e du fait d\u2019un PSA \u00e9lev\u00e9, sans confirmation possible par les examens standards. Tous ont re\u00e7u Pylclari et un TEP : une l\u00e9sion canc\u00e9reuse a \u00e9t\u00e9 d\u00e9tect\u00e9e chez 59 \u00e0 66 % des patients selon le lecteur, et la localisation de la l\u00e9sion a \u00e9t\u00e9 correctement identifi\u00e9e dans 85 \u00e0 87 % des cas. Une troisi\u00e8me \u00e9tude a inclus 215 hommes suspect\u00e9s de r\u00e9cidive apr\u00e8s traitement. Chaque patient a re\u00e7u Pylclari ou la 18F-fluorocholine (autre m\u00e9dicament de diagnostic) avant un TEP, puis l\u2019autre produit dans les 12 jours avec un second TEP. Le cancer de la prostate a \u00e9t\u00e9 d\u00e9tect\u00e9 chez 58 % des patients apr\u00e8s injection de Pylclari, contre 40 % apr\u00e8s 18F-fluorocholine, sugg\u00e9rant une performance diagnostique sup\u00e9rieure. Les effets ind\u00e9sirables et contre-indications sont d\u00e9taill\u00e9s dans la notice du m\u00e9dicament, sans pr\u00e9cision chiffr\u00e9e dans le texte. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/pylclari\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Le document pr\u00e9sente Pylclari, m\u00e9dicament de diagnostic \u00e0 base de piflufolastat (18F) destin\u00e9 aux adultes atteints de cancer de la prostate. Il est utilis\u00e9 en tomographie par \u00e9mission de positons [&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-20450","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\/20450","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=20450"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20450\/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=20450"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20450"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20450"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}