{"id":37065,"date":"2018-09-21T09:00:00","date_gmt":"2018-09-21T07:00:00","guid":{"rendered":"https:\/\/www.ipsen.com\/?post_type=press_release&#038;p=37065"},"modified":"2023-09-06T23:26:31","modified_gmt":"2023-09-06T21:26:31","slug":"ipsen-recoit-un-avis-positif-du-chmp-pour-cabometyx-cabozantinib-dans-le-traitement-en-seconde-ligne-des-patients-atteints-de-carcinome-hepatocellulaire-chc","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/fr\/press-releases\/ipsen-recoit-un-avis-positif-du-chmp-pour-cabometyx-cabozantinib-dans-le-traitement-en-seconde-ligne-des-patients-atteints-de-carcinome-hepatocellulaire-chc\/","title":{"rendered":"Ipsen re\u00e7oit un avis positif du CHMP pour Cabometyx\u00ae (cabozantinib) dans le traitement en seconde ligne des patients atteints de carcinome h\u00e9patocellulaire (CHC)"},"content":{"rendered":"<p><b>Paris, France, 21 septembre 2018 \u2013 Ipsen (Euronext : IPN ; ADR : IPSEY) a annonc\u00e9 aujourd\u2019hui que le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP : Committee for Medicinal Products for Human Use), comit\u00e9 scientifique de l\u2019Agence europ\u00e9enne du m\u00e9dicament (EMA : European Medicines Agency) a \u00e9mis un avis favorable pour Cabometyx\u00ae (cabozantinib) en monoth\u00e9rapie dans le traitement du carcinome h\u00e9patocellulaire (CHC) de l\u2019adulte trait\u00e9 ant\u00e9rieurement par soraf\u00e9nib.<\/b> L\u2019avis favorable du CHMP va maintenant \u00eatre examin\u00e9 par la Commission europ\u00e9enne (CE), qui a la comp\u00e9tence pour approuver la mise sur le march\u00e9 des m\u00e9dicaments dans l\u2019Union europ\u00e9enne (UE).<br \/>\nLe docteur Alexandre Lebeaut, Vice-Pr\u00e9sident Ex\u00e9cutif, R&amp;D et Chief Scientific Officer Ipsen a d\u00e9clar\u00e9 :<\/p>\n<blockquote><p>\u00ab \u00ab Le cancer du foie repr\u00e9sente une maladie en constante augmentation et malgr\u00e9 la d\u00e9couverte r\u00e9cente de nouvelles mol\u00e9cules, il reste la seconde cause la plus importante de d\u00e9c\u00e8s par cancer au monde. Pour faire suite \u00e0 l\u2019avis positif du CHMP publi\u00e9 aujourd\u2019hui, et s\u2019il est approuv\u00e9 par la Commission europ\u00e9enne, Cabometyx\u00ae en monoth\u00e9rapie offrira aux patients atteints d\u2019un carcinome h\u00e9patocellulaire une nouvelle option th\u00e9rapeutique sous forme orale tr\u00e8s utile. \u00bb \u00bb<\/p><\/blockquote>\n<p>Le docteur Lorenza Rimassa, Unit\u00e9 d\u2019oncologie m\u00e9dicale, Humanitas Cancer Center, Milan, a d\u00e9clar\u00e9 :<\/p>\n<blockquote><p>\u00ab \u00ab La communaut\u00e9 m\u00e9dicale se r\u00e9jouit que le CHMP ait donn\u00e9 un avis positif pour Cabometyx\u00ae dans le traitement des patients atteints d\u2019un carcinome h\u00e9patocellulaire ant\u00e9rieurement trait\u00e9s. L\u2019\u00e9tude de phase 3 CELESTIAL, qui a permis de d\u00e9montrer que Cabometyx\u00ae apporte un b\u00e9n\u00e9fice clinique significatif sur la survie globale et la survie sans progression, confirme la valeur apport\u00e9e aux patients atteints de ce cancer difficile \u00e0 traiter. \u00bb \u00bb<\/p><\/blockquote>\n<p>La demande d\u2019autorisation de mise sur le march\u00e9 aupr\u00e8s de l\u2019EMA repose sur les r\u00e9sultats de l\u2019\u00e9tude internationale contr\u00f4l\u00e9e versus placebo de phase 3 CELESTIAL qui a atteint son objectif principal de survie globale (OS), le cabozantinib ayant permis d\u2019obtenir une am\u00e9lioration statistiquement significative et cliniquement pertinente de la survie globale en comparaison au placebo chez des patients atteints d\u2019un carcinome h\u00e9patocellulaire (CHC) avanc\u00e9, trait\u00e9s ant\u00e9rieurement par soraf\u00e9nib. En juillet 2018, les r\u00e9sultats de l\u2019\u00e9tude pivotale de phase III CELESTIAL ont \u00e9t\u00e9 publi\u00e9s dans la revue <em>New England Journal of Medicine<\/em>1.<br \/>\nL\u2019avis positif du CHMP publi\u00e9 aujourd\u2019hui fait suite \u00e0 deux pr\u00e9c\u00e9dentes approbations de Cabometyx\u00ae dans le traitement du carcinome r\u00e9nal.<\/p>\n<p>1. Abou-Alfa, G, Meyer T, Cheng AL, et al. Cabozantinib in patients with advanced and progressing hepatocellular carcinoma. N Engl J Med. 2018.<\/p>\n<p><img src='https:\/\/ml-eu.globenewswire.com\/media\/NDJmMjY3NzItNjQ3Mi00MTgyLWFlYjQtYTQxYzU3OGU0MmYwLTEwMTA5NDM=\/tiny\/Ipsen-SA.png' \/><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"template":"","categories":[1233,3556],"tags":[],"class_list":["post-37065","press_release","type-press_release","status-publish","hentry","category-pressrelease-fr","category-corporate-pressrelease-fr","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Ipsen re\u00e7oit un avis positif du CHMP pour Cabometyx\u00ae (cabozantinib) dans le traitement en seconde ligne des patients atteints de carcinome h\u00e9patocellulaire (CHC)<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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