{"id":45779,"date":"2022-09-13T09:32:05","date_gmt":"2022-09-13T13:32:05","guid":{"rendered":"https:\/\/wfh.org\/biomarin-signale-un-nouvel-evenement-indesirable-grave-dans-son-essai-clinique-de-therapie-genique-pour-lhemophilie-a\/"},"modified":"2024-04-10T09:51:01","modified_gmt":"2024-04-10T13:51:01","slug":"biomarin-signale-un-nouvel-evenement-indesirable-grave-dans-son-essai-clinique-de-therapie-genique-pour-lhemophilie-a","status":"publish","type":"post","link":"https:\/\/wfh.org\/fr\/article\/biomarin-signale-un-nouvel-evenement-indesirable-grave-dans-son-essai-clinique-de-therapie-genique-pour-lhemophilie-a\/","title":{"rendered":"BioMarin signale un nouvel \u00e9v\u00e9nement ind\u00e9sirable grave dans son essai clinique de th\u00e9rapie g\u00e9nique pour l\u2019h\u00e9mophilie A"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"45779\" class=\"elementor elementor-45779 elementor-45405\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2efce76 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2efce76\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-02947f3\" data-id=\"02947f3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b551173 gallery-spacing-custom elementor-widget elementor-widget-image-gallery\" data-id=\"b551173\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image-gallery.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-image-gallery\">\n\t\t\t<div id='gallery-1' class='gallery galleryid-45779 gallery-columns-3 gallery-size-full'><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon landscape'>\n\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"770\" height=\"350\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/EHC.png\" class=\"attachment-full size-full\" alt=\"Logo European haemophilia consortium\" srcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/EHC.png 770w, https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/EHC-300x136.png 300w, https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/EHC-768x349.png 768w\" sizes=\"(max-width: 770px) 100vw, 770px\" \/>\n\t\t\t<\/div><\/figure><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon landscape'>\n\t\t\t\t<img decoding=\"async\" width=\"600\" height=\"300\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/12\/NHF-logo.png\" class=\"attachment-full size-full\" alt=\"\" srcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/12\/NHF-logo.png 600w, https:\/\/wfh.org\/wp-content\/uploads\/2021\/12\/NHF-logo-300x150.png 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\n\t\t\t<\/div><\/figure><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon landscape'>\n\t\t\t\t<img decoding=\"async\" width=\"1277\" height=\"603\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/04\/WFH-trilingual-logo-EN.png\" class=\"attachment-full size-full\" alt=\"\" aria-describedby=\"gallery-1-29974\" srcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/04\/WFH-trilingual-logo-EN.png 1277w, https:\/\/wfh.org\/wp-content\/uploads\/2021\/04\/WFH-trilingual-logo-EN-192x91.png 192w, https:\/\/wfh.org\/wp-content\/uploads\/2021\/04\/WFH-trilingual-logo-EN-768x363.png 768w\" sizes=\"(max-width: 1277px) 100vw, 1277px\" \/>\n\t\t\t<\/div>\n\t\t\t\t<figcaption class='wp-caption-text gallery-caption' id='gallery-1-29974'>\n\t\t\t\tstock\n\t\t\t\t<\/figcaption><\/figure>\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3d0b02 elementor-widget elementor-widget-text-editor\" data-id=\"a3d0b02\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\u00ab\u00a0\u00c9v\u00e9nement ind\u00e9sirable grave\u00a0\u00bb (EIG) est le terme utilis\u00e9 pour d\u00e9crire la survenue d\u2019un probl\u00e8me de sant\u00e9 grave au cours d\u2019une \u00e9tude, que le traitement exp\u00e9rimental en soit ou non \u00e0 l\u2019origine.\r\n\r\nRoctavian\u2122 (valoctocog\u00e8ne roxaparvovec) est une th\u00e9rapie g\u00e9nique pour le traitement de l\u2019h\u00e9mophilie\u00a0A s\u00e9v\u00e8re chez l\u2019adulte. Le 24\u00a0ao\u00fbt, la Commission europ\u00e9enne lui a accord\u00e9 une autorisation de mise sur le march\u00e9 conditionnelle. Cette th\u00e9rapie est en cours d\u2019examen par la <em>Food and Drug Administration<\/em> (FDA) des \u00c9tats-Unis en vue d\u2019une potentielle autorisation.\r\n\r\nEn ao\u00fbt 2022, BioMarin a annonc\u00e9 la d\u00e9couverte d\u2019une leuc\u00e9mie aigu\u00eb lymphoblastique \u00e0 pr\u00e9curseurs\u00a0B (LAL-B) chez l\u2019un des participants \u00e0 son essai clinique de phase\u00a0III qui avait re\u00e7u la th\u00e9rapie g\u00e9nique trois ans auparavant. BioMarin d\u00e9clare que les analyses sanguines initiales ont mis en \u00e9vidence de faibles taux de vecteur et d\u2019autres facteurs, coh\u00e9rents avec les r\u00e9sultats g\u00e9n\u00e9ralement observ\u00e9s dans le diagnostic de LAL-B, amenant le comit\u00e9 de surveillance des donn\u00e9es (DMC) \u00e0 consid\u00e9rer que l\u2019EIG n\u2019est probablement pas li\u00e9 \u00e0 la th\u00e9rapie g\u00e9nique. Le patient est actuellement trait\u00e9 par chimioth\u00e9rapie standard.\r\n\r\nBioMarin fera appel \u00e0 une soci\u00e9t\u00e9 externe pour mener un s\u00e9quen\u00e7age de g\u00e9nome entier et s\u2019engage \u00e0 en communiquer publiquement les r\u00e9sultats. BioMarin a signal\u00e9 ce cas aux autorit\u00e9s r\u00e9glementaires (EMA, FDA, etc.). \u00c0 ce stade, aucun changement dans la conduite de l\u2019\u00e9tude ni la r\u00e9\u00e9valuation de l\u2019autorisation de mise sur le march\u00e9 conditionnelle n\u2019a \u00e9t\u00e9 demand\u00e9.\r\n\r\nEn d\u00e9but d\u2019ann\u00e9e, BioMarin a fait \u00e9tat d\u2019un cancer des glandes salivaires apparu chez l\u2019un des participants \u00e0 l\u2019\u00e9tude de phase\u00a0I\/II ayant re\u00e7u la th\u00e9rapie g\u00e9nique plus de cinq ans auparavant. L\u2019analyse g\u00e9nomique men\u00e9e par le m\u00eame prestataire a conclu en avril 2022 \u00e0 l\u2019absence de lien entre le cancer et la th\u00e9rapie g\u00e9nique. La conclusion \u00e9tait la suivante\u00a0: \u00ab\u00a0<em>Les r\u00e9sultats ont montr\u00e9 un sch\u00e9ma d\u2019int\u00e9gration comparable entre tissus sains et tumoraux, sans qu\u2019\u00e9merge la preuve que l\u2019int\u00e9gration du vecteur ait contribu\u00e9 \u00e0 la masse de la glande salivaire<\/em>\u00a0\u00bb. Les d\u00e9clarations ant\u00e9rieures \u00e0 ce sujet sont disponibles ci-dessous<sup>12<\/sup>.\r\n\r\nIl s\u2019agit du troisi\u00e8me signalement de cancer (les deux autres \u00e9tant un cancer h\u00e9patique et un cancer des amygdales) chez des participants \u00e0 un essai de th\u00e9rapie g\u00e9nique pour l\u2019h\u00e9mophilie. \u00c0 ce jour, aucun lien n\u2019a \u00e9t\u00e9 \u00e9tabli entre ces \u00e9v\u00e9nements et la th\u00e9rapie g\u00e9nique. Pour plus d\u2019informations, consultez les d\u00e9clarations ant\u00e9rieures<sup>23<\/sup>.\r\n\r\nLe risque potentiel de cancer est en g\u00e9n\u00e9ral au centre de l\u2019attention de toutes les th\u00e9rapies g\u00e9niques. L\u2019EHC, la FMH et la NHF, au nom de la communaut\u00e9 des patients, restent vigilants et insistent sur le passage au crible et l\u2019examen de chacun des EIG dans ces th\u00e9rapies, comme dans toutes. Cela contribue \u00e0 garantir la s\u00e9curit\u00e9 future de ces traitements qui peuvent changer la vie.\r\n\r\nTout en faisant preuve de vigilance, nous devons \u00e9galement rester conscients du risque de base de cancer dans la population g\u00e9n\u00e9rale, y compris chez les personnes atteintes de troubles de la coagulation. Outre le risque d\u2019une forme de cancer dans la population g\u00e9n\u00e9rale, il existe par ailleurs un risque accru de cancer h\u00e9patique chez les patients h\u00e9mophiles ayant des ant\u00e9c\u00e9dents de VIH et d\u2019h\u00e9patite\u00a0C et\/ou B.\r\n\r\nNous devons continuer \u00e0 demander aux investigateurs, aux cliniciens, aux entreprises et aux autorit\u00e9s r\u00e9glementaires de poursuivre leurs efforts pour distinguer un EIG d\u2019un risque de base g\u00e9n\u00e9ral de la mani\u00e8re la plus opportune possible de sorte que les patients puissent prendre les d\u00e9cisions concernant les futurs traitements sur la base de l\u2019ensemble des preuves disponibles.\r\n\r\nLa surveillance des probl\u00e8mes de s\u00e9curit\u00e9 pour une technologie nouvelle comme la th\u00e9rapie g\u00e9nique est essentielle pour notre communaut\u00e9. \u00c0 cette fin, le <a href=\"https:\/\/wfh.org\/usa\/research-and-data-collection\/#gtr\" target=\"_blank\" rel=\"noopener\">Registre de la th\u00e9rapie g\u00e9nique de la FMH<\/a> est en cours de d\u00e9veloppement pour enregistrer la plupart ou l\u2019ensemble des patients recevant une th\u00e9rapie g\u00e9nique \u00e0 mesure que ces produits sont autoris\u00e9s.\r\n\r\nLes trois organisations continueront \u00e0 surveiller et \u00e0 communiquer tous les \u00e9v\u00e9nements li\u00e9s \u00e0 la s\u00e9curit\u00e9 dans tous les domaines th\u00e9rapeutiques relevant de notre communaut\u00e9 de patients.\r\n\r\nPour lire cette d\u00e9claration au format PDF, <a href=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/09\/2022_09_12_Joint-Statement-on-BioMarin-SAE-in-GT-Trial_FINAL.pdf(enanglais)\" target=\"_blank\" rel=\"noopener\">cliquez ici<\/a>.\r\n\r\n<sup>1<\/sup>\u00a0<a href=\"https:\/\/www.ehc.eu\/biomarin-follows-up-on-previously-reported-serious-adverse-event-in-its-phase-i-ii-gene-therapy-clinical-trial-for-haemophilia-a\" target=\"_blank\" rel=\"noopener\">https:\/\/www.ehc.eu\/biomarin-follows-up-on-previously-reported-serious-adverse-event-in-its-phase-i-ii-gene-therapy-clinical-trial-for-haemophilia-a\/ (en anglais)<\/a>\r\n\r\n<sup>2<\/sup> <a href=\"https:\/\/www.ehc.eu\/biomarin-reports-a-serious-adverse-event-for-its-phase-i-ii-gene-therapy-trial-for-haemophilia-a\" target=\"_blank\" rel=\"noopener\">https:\/\/www.ehc.eu\/biomarin-reports-a-serious-adverse-event-for-its-phase-i-ii-gene-therapy-trial-for-haemophilia-a\/ (en anglais)<\/a>\r\n\r\n<sup>3<\/sup>\u00a0<a href=\"https:\/\/www.ehc.eu\/8702\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.ehc.eu\/8702\/<\/a>\r\n\r\nR\u00e9f\u00e9rences suppl\u00e9mentaires\u00a0:\r\n\r\n<a href=\"https:\/\/can01.safelinks.protection.outlook.com\/?url=https%3A%2F%2Fwfh.org%2Fbiomarin-follows-up-on-previously-reported-serious-adverse-event-in-its-phase-i-ii-gene-therapy-clinical-trial-for-haemophilia-a%2F&amp;data=05%7C01%7Cmsemienchuk%40wfh.org%7Cfb83775e6dfa46ab04d208da9597fd47%7Cac8b0aef17b84870998367a82a6bcc3f%7C0%7C0%7C637986777261990793%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=ZNuEzuoXCx3Tta1qN7gBJ3s16T8SVtaGQ0hsRntFPvM%3D&amp;reserved=0\" target=\"_blank\" rel=\"noopener\">https:\/\/wfh.org\/fr\/biomarin-fait-suite-a-un-evenement-indesirable-grave-precedemment-signale-dans-son-essai-clinique-de-therapie-genique-de-phase-i-ii-pour-lhemophilie-a\/<\/a>\r\n\r\n<a href=\"https:\/\/can01.safelinks.protection.outlook.com\/?url=https%3A%2F%2Fwfh.org%2Funiqure-reports-development-of-hepatocellular-carcinoma-in-a-gene-therapy-clinical-trial-participant%2F&amp;data=05%7C01%7Cmsemienchuk%40wfh.org%7Cfb83775e6dfa46ab04d208da9597fd47%7Cac8b0aef17b84870998367a82a6bcc3f%7C0%7C0%7C637986777261990793%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=4b9hQ5VhwthhZezRdCL8%2Fb8DNbW7MGX9z028VwINoS8%3D&amp;reserved=0\" target=\"_blank\" rel=\"noopener\">https:\/\/wfh.org\/fr\/uniqure-declare-le-developpement-dun-carcinome-hepatocellulaire-dans-un-essai-clinique-de-therapie-genique\/<\/a>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3fa23c5 elementor-widget elementor-widget-spacer\" data-id=\"3fa23c5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>13 septembre 2022 \u2013 BioMarin annonce une mise \u00e0 jour de son essai clinique de phase III contenant des informations \u00e0 propos d\u2019un nouvel \u00e9v\u00e9nement ind\u00e9sirable grave (EIG) observ\u00e9 chez un participant \u00e0 l\u2019\u00e9tude sur Roctavian\u2122 (valoctocog\u00e8ne roxaparvovec).<\/p>\n","protected":false},"author":13,"featured_media":30514,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[177,197],"tags":[],"search-category":[85],"class_list":["post-45779","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualite-medicale","category-declarations-publiques-et-recommandations-de-la-fmh","search-category-article"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>BioMarin signale un nouvel \u00e9v\u00e9nement ind\u00e9sirable grave dans son essai clinique de th\u00e9rapie g\u00e9nique pour l\u2019h\u00e9mophilie A | FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/wfh.org\/fr\/article\/biomarin-signale-un-nouvel-evenement-indesirable-grave-dans-son-essai-clinique-de-therapie-genique-pour-lhemophilie-a\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BioMarin signale un nouvel \u00e9v\u00e9nement ind\u00e9sirable grave dans son essai clinique de th\u00e9rapie g\u00e9nique pour l\u2019h\u00e9mophilie A\" \/>\n<meta property=\"og:description\" content=\"13 septembre 2022 \u2013 BioMarin annonce une mise \u00e0 jour de son essai clinique de phase III contenant des informations \u00e0 propos d\u2019un nouvel \u00e9v\u00e9nement ind\u00e9sirable grave (EIG) observ\u00e9 chez un participant \u00e0 l\u2019\u00e9tude sur Roctavian\u2122 (valoctocog\u00e8ne roxaparvovec).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/wfh.org\/fr\/article\/biomarin-signale-un-nouvel-evenement-indesirable-grave-dans-son-essai-clinique-de-therapie-genique-pour-lhemophilie-a\/\" \/>\n<meta property=\"og:site_name\" content=\"FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/wfhemophilia\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-09-13T13:32:05+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-04-10T13:51:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/03\/WFH-statement-News-FR.png\" \/>\n\t<meta property=\"og:image:width\" content=\"2501\" \/>\n\t<meta property=\"og:image:height\" content=\"1459\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Mitch Semienchuk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mitch Semienchuk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/wfh.org\/fr\/article\/biomarin-signale-un-nouvel-evenement-indesirable-grave-dans-son-essai-clinique-de-therapie-genique-pour-lhemophilie-a\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/biomarin-signale-un-nouvel-evenement-indesirable-grave-dans-son-essai-clinique-de-therapie-genique-pour-lhemophilie-a\/\"},\"author\":{\"name\":\"Mitch Semienchuk\",\"@id\":\"https:\/\/wfh.org\/fr\/#\/schema\/person\/4aea5b13c1966452a640eef39423925b\"},\"headline\":\"BioMarin signale un nouvel \u00e9v\u00e9nement ind\u00e9sirable grave dans son essai clinique de th\u00e9rapie g\u00e9nique 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