L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a publi\u00e9, le 16 septembre 2026, une d\u00e9cision modifiant le cadre de prescription compassionnelle de Tibsovo (ivosid\u00e9nib) 250 mg, comprim\u00e9 pellicul\u00e9, dans l\u2019indication du gliome de bas grade avec mutation IDH1. Le m\u00e9dicament est utilis\u00e9 en monoth\u00e9rapie chez des patients adultes inop\u00e9rables, ne r\u00e9pondant pas au traitement ou en progression apr\u00e8s une radioth\u00e9rapie (ou in\u00e9ligibles \u00e0 celle-ci) et apr\u00e8s au moins une ligne de chimioth\u00e9rapie \u00e0 base de t\u00e9mozolomide (ou in\u00e9ligibles \u00e0 celle-ci).<\/p>\n
Cette d\u00e9cision intervient dans le cadre du dispositif d\u2019acc\u00e8s d\u00e9rogatoire aux m\u00e9dicaments pr\u00e9vu par le code de la sant\u00e9 publique (articles L. 5121-12-1 III, L. 5121-14-3 et R. 5121-76-9) et s\u2019inscrit dans la continuit\u00e9 du cadre de prescription compassionnelle \u00e9tabli le 13 f\u00e9vrier 2024. \u00c0 la suite d\u2019une demande des laboratoires Servier en date du 21 juillet 2025, l\u2019ANSM a \u00e9valu\u00e9 et approuv\u00e9 une mise \u00e0 jour du protocole d\u2019utilisation th\u00e9rapeutique et de suivi des patients (PUT-SP), visant \u00e0 simplifier la collecte de donn\u00e9es, ainsi qu\u2019une modification de l\u2019annexe 3 relative \u00e0 la note d\u2019information destin\u00e9e aux patients.<\/p>\n
L\u2019ANSM pr\u00e9cise que ces modifications du PUT-SP n\u2019ont pas d\u2019impact sur la dur\u00e9e de validit\u00e9 du cadre de prescription compassionnelle. Les principaux acteurs mentionn\u00e9s sont l\u2019ANSM, qui encadre la s\u00e9curit\u00e9 et l\u2019acc\u00e8s d\u00e9rogatoire au m\u00e9dicament, et les laboratoires Servier, \u00e0 l\u2019initiative de la demande de simplification des modalit\u00e9s de recueil des donn\u00e9es de suivi. Cette \u00e9volution concerne la pratique de suivi des patients dans le cadre d\u2019un traitement compassionnel pour une pathologie grave et inop\u00e9rable, sans modification annonc\u00e9e du p\u00e9rim\u00e8tre des patients \u00e9ligibles ni des conditions m\u00e9dicales d\u2019utilisation.\u00a0(contenu r\u00e9sum\u00e9 par l’IA)Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":" L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a publi\u00e9, le 16 septembre 2026, une d\u00e9cision modifiant le cadre de prescription compassionnelle de Tibsovo (ivosid\u00e9nib) 250 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