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Taiho Pharmaceutical présente une demande d'homologation pour la fabrication et la commercialisation du nouvel agent antitumoral TAS-102
Date:2/26/2013

TOKYO, 27 février 2013 /PRNewswire/ -- Taiho Pharmaceutical Co., Ltd. a annoncé le 27 février avoir présenté le 26 février une demande d'homologation pour la fabrication et la commercialisation du nouvel agent antitumoral nucléoside administré par voie orale, le TAS-102 (mélange de Trifluorothymidine [FTD] et de tipiracil hydrochloride[TPI]), auprès du Ministère japonais de la Santé publique et du Travail. Taiho Pharmaceutical cherche à obtenir l'homologation pour le TAS-102 de l'indication contre le cancer colorectal récurrent à un stade avancé, non résécable.

La demande d'homologation se base sur les résultats de l'essai clinique de phase II (Étude 10040030) effectué dans 20 centres médicaux au Japon. C'est un essai à répartition aléatoire, mené en double insu pour comparer le TAS-102 à un placébo. Il porte sur 172 patients souffrant de cancer colorectal récurrent à un stade avancé, non résécable et réfractaire aux chimiothérapies standard d'au moins deux régimes contenant un mélange de fluoropyrimidine, d'irinotécan et d'oxaliplatine. Selon les résultats, le groupe à qui le TAS-102 a été administré a vu son taux de survie s'améliorer (durée médiane de survie globale : 9 mois contre 6,6 mois) et le risque de mortalité significativement réduire (HR : 0.56, p=0.0011). L'effet secondaire au médicament CTCAE de niveau 3 ou plus le plus fréquemment rapporté est la neutropénie. La diarrhée, la fatigue, la nausée et autres effets secondaires de niveau 3 n'ont pas dépassé les 10 %. Taiho Pharmaceutical mène actuellement un essai clinique mondial de phase III portant sur le TAS-102 sur une population similaire souffrant d'un cancer colorectal (RECOURSE
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SOURCE Taiho Pharmaceutical Co., Ltd.
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