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Taiho Pharmaceutical ansöker om godkännande att tillverka och sälja det nya antitumörpreparatet TAS-102
Date:2/26/2013
ntemot placebo. Detta är en global fas-III studie som kommer att omfatta totalt 800 patienter från Japan, Nordamerika, Europa och Australien. Registreringen av patienter började i juni 2012. De patienter som deltar har icke resektabel, avancerad, återkommande kolorektal cancer som är refraktär mot standardcytostatika (fluoropyrimidin, irinotekan, oxaliplatin, bevacizumab samt, för patienter med tumörer som innehåller vildtyp av KRAS-genen, en anti-EGFR monoklonal antikropp). Studien kommer att jämföra patienter som slumpmässigt tilldelats TAS-102 eller placebo för att undersöka effektiviteten och säkerheten hos TAS-102. Det primära effektmåttet är total överlevnad. De huvudansvariga forskarna är Dr. Atsushi Otsu , direktör för det kliniska utvecklingscentrat på National Cancer Center Hospital East (Japan), Dr. Robert J. Mayer från Dana Farber Cancer Institute (USA), samt Dr. Eric Van Cutsem från universitetssjukhuset i Gasthuisberg (Belgium).
Om Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical, ett dotterbolag till Otsuka Holdings Co., Ltd. (http://www.otsuka.com/en/), är ett forskningsdrivet specialiserat läkemedelsföretag som fokuserar på de tre områdena onkologi, allergier och immunologi, samt urologi. Dess företagsfilosofi är formulerat som en utfästelse: "Vi strävar efter att förbättra människors hälsa och bidra till ett bättre samhälle." Särskilt inom onkologiområdet är Taiho Pharmaceutical känt som ett av de ledande företagen i Japan och runt om i världen när det gäller utveckling
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| SOURCE Taiho Pharmaceutical Co., Ltd. Copyright©2012 PR Newswire. All rights reserved |
Related medicine technology :
1. Taiho Pharmaceutical Announces Start of Global Phase III Clinical Trial in Metastatic Colorectal Cancer with Novel Antitumor Agent TAS-102
2. Taiho Pharmaceutical présente une demande dhomologation pour la fabrication et la commercialisation du nouvel agent antitumoral TAS-102
3. Taiho Pharmaceutical Submits Application for Approval to Manufacture and Market Novel Antitumor Agent TAS-102
4. Taiho Pharmaceutical stellt Zulassungsantrag zur Herstellung und Vermarktung des neuartigen Antitumormittels TAS-102
5. Taiho Pharmaceutical presenta una solicitud para fabricar y comercializar el nuevo agente antitumoral TAS-102
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