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Taiho Pharmaceutical ansöker om godkännande att tillverka och sälja det nya antitumörpreparatet TAS-102
Date:2/26/2013

TOKYO, 27 februari 2013 /PRNewswire/ -- Taiho Pharmaceutical Co., Ltd. annonserade den 27 februari att man den 26 februari hade lämnat in en ansökan om godkännande för att tillverka och marknadsföra det nya perorala nukleosida antitumörpreparatet TAS-102 (en kombination av trifluorotymidin (FTD) och tipiracil-hydrochloride (TPI) ), till den japanska myndigheten för hälsovård, arbete och välfärd. Taiho Pharmaceutical söker godkännande av TAS-102 för indikationen icke-resektabel, avancerad, återkommande kolorektal cancer.

Ansökan om godkännande är baserad på resultaten från en klinisk fas II-studie (Studie 10040030) som genomförts vid 20 vårdinrättningar i hela Japan. Den var en randomiserad, dubbelblind jämförande studie mellan TAS-102 och placebo med 172 patienter med icke resektabel, avancerad, återkommande kolorektal cancer som var refraktär mot standardcytostatikabehandlingen som består av minst två behandlingsregimer innehållande fluoropyrimidin, irinotekan eller oxaliplatin. Resultaten visade att den grupp som fick TAS-102 hade en längre total överlevnad (medianvärde för total överlevnad: 9,0 månader gentemot 6,6 månader) och en signifikant minskad mortalitetsrisk (HR: 0,56, p=0,0011). Den vanligaste rapporterade läkemedelsbiverkningen med en CTCAE-grad på 3 eller högre var neutropeni. Förekomsten av diarré, trötthet, yrsel och andra biverkningar av grad 3 eller högre översteg ej 10 %. Taiho Pharmaceutical genomför för närvarande en global fas III-studie av TAS-102 hos en liknande patientpopulation med kolorektal cancer (RECOURSE) med den slutgiltiga målsättningen att preparatet ska godkännas och säljas i hela världen.

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SOURCE Taiho Pharmaceutical Co., Ltd.
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