Le laboratoire Daiichi Sankyo France a d\u00e9pos\u00e9 le 27 mai 2026, puis compl\u00e9t\u00e9 les 10 juin, 11 ao\u00fbt et 8 septembre 2026, une demande aupr\u00e8s des autorit\u00e9s comp\u00e9tentes pour la sp\u00e9cialit\u00e9 Enhertu 100 mg, poudre pour solution \u00e0 diluer pour perfusion (trastuzumab d\u00e9ruxt\u00e9can). L\u2019indication th\u00e9rapeutique revendiqu\u00e9e concerne l\u2019utilisation d\u2019Enhertu en monoth\u00e9rapie, en traitement adjuvant chez des patients adultes atteints d\u2019un cancer du sein HER2-positif r\u00e9s\u00e9qu\u00e9, pr\u00e9sentant une maladie invasive r\u00e9siduelle apr\u00e8s un traitement n\u00e9oadjuvant \u00e0 base de taxane et ciblant HER2. La s\u00e9lection des patients doit \u00eatre fond\u00e9e sur des biomarqueurs, conform\u00e9ment \u00e0 la rubrique 4.2 du r\u00e9sum\u00e9 des caract\u00e9ristiques du produit (RCP).<\/p>\n
L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) atteste d\u2019une forte pr\u00e9somption d\u2019efficacit\u00e9 et de s\u00e9curit\u00e9 d\u2019Enhertu 100 mg dans cette indication th\u00e9rapeutique modifi\u00e9e. Cet avis, dat\u00e9 du 18 septembre 2026 et sign\u00e9 \u00e0 Saint-Denis par le Directeur Europe et innovation, Pierre-Olivier Farenq, constitue un \u00e9l\u00e9ment important pour le suivi des politiques de sant\u00e9 en mati\u00e8re de prise en charge des cancers du sein HER2-positifs en situation adjuvante apr\u00e8s traitement n\u00e9oadjuvant.\u00a0(contenu r\u00e9sum\u00e9 par l’IA)Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":" Le laboratoire Daiichi Sankyo France a d\u00e9pos\u00e9 le 27 mai 2026, puis compl\u00e9t\u00e9 les 10 juin, 11 ao\u00fbt et 8 septembre 2026, une demande aupr\u00e8s des autorit\u00e9s comp\u00e9tentes pour la 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