L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) met \u00e0 jour le cadre de prescription compassionnelle (CPC) d\u2019une sp\u00e9cialit\u00e9 pharmaceutique, sans en modifier la dur\u00e9e de validit\u00e9. Cette d\u00e9cision intervient dans le contexte d\u2019un changement de laboratoire exploitant et fait suite \u00e0 une demande de mise \u00e0 jour formul\u00e9e le 15 d\u00e9cembre 2025 par le laboratoire Novartis Pharma SAS, portant sur les indications th\u00e9rapeutiques et certaines rubriques du protocole d\u2019utilisation th\u00e9rapeutique et de suivi des patients (PUT-SP). L\u2019ANSM a \u00e9valu\u00e9 ces demandes avant de valider les modifications.<\/p>\n
Les nouvelles indications concernent des pathologies tumorales rares ou complexes exprimant des r\u00e9cepteurs de la somatostatine et document\u00e9es par imagerie TEP adapt\u00e9e. Sont d\u00e9sormais vis\u00e9s : les ph\u00e9ochromocytomes\/paragangliomes (PPGL) m\u00e9tastatiques ou localement avanc\u00e9s inop\u00e9rables, progressifs ou s\u00e9cr\u00e9tants non contr\u00f4l\u00e9s, en lien avec les r\u00e9sultats des TEP au FDG et\/ou \u00e0 la Fdopa et apr\u00e8s proposition d\u2019une r\u00e9union de concertation pluridisciplinaire (RCP) r\u00e9gionale Comete ; les tumeurs neuroendocrines (TNE) bronchiques m\u00e9tastatiques ou localement avanc\u00e9es inop\u00e9rables, progressives ou s\u00e9cr\u00e9tantes non contr\u00f4l\u00e9es, apr\u00e8s \u00e9chec ou contre-indication d\u2019un traitement par \u00e9v\u00e9rolimus, sur proposition de la RCP r\u00e9gionale Renaten ; les TNE thymiques m\u00e9tastatiques ou localement avanc\u00e9es inop\u00e9rables, progressives ou s\u00e9cr\u00e9tantes non contr\u00f4l\u00e9es, sur proposition de la RCP r\u00e9gionale Renaten ; les TNE, y compris de primitif inconnu, m\u00e9tastatiques ou localement avanc\u00e9es inop\u00e9rables, progressives ou s\u00e9cr\u00e9tantes non contr\u00f4l\u00e9es, ne relevant pas de l\u2019indication de l\u2019autorisation de mise sur le march\u00e9 (hors TNE-GEP bien diff\u00e9renci\u00e9es G1\/G2), sur proposition de la RCP r\u00e9gionale Renaten ; enfin, les m\u00e9ningiomes de tous grades exprimant les r\u00e9cepteurs de la somatostatine de type 2, apr\u00e8s \u00e9chec des traitements de r\u00e9f\u00e9rence (chirurgie, radioth\u00e9rapie\/radiochirurgie).<\/p>\n
Le dispositif rel\u00e8ve du 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 le CPC initialement \u00e9tabli le 5 avril 2022 et renouvel\u00e9 le 2 avril 2025. Il illustre l\u2019usage du cadre compassionnel pour des indications non couvertes par l\u2019AMM, dans un contexte de prise en charge sp\u00e9cialis\u00e9e, encadr\u00e9e par l\u2019ANSM et les r\u00e9seaux r\u00e9gionaux de RCP (Comete, Renaten), avec un suivi structur\u00e9 des patients via le PUT-SP.\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) met \u00e0 jour le cadre de prescription compassionnelle (CPC) d\u2019une sp\u00e9cialit\u00e9 pharmaceutique, sans en modifier la dur\u00e9e de 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