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Taiho Pharmaceutical stellt Zulassungsantrag zur Herstellung und Vermarktung des neuartigen Antitumormittels TAS-102
Date:2/26/2013

TOKIO, 27. Februar 2013 /PRNewswire/ -- Taiho Pharmaceutical Co., Ltd. gab am 27. Februar bekannt, dass das Unternehmen am 26. Februar einen Zulassungsantrag zur Herstellung und Vermarktung des neuartigen, oral verabreichten Nukleosid-Antitumormittels TAS-102 (eine Kombination aus Trifluorthymidin (FTD) und Tipiracil-Hydrochlorid (TPI)) beim japanischen Ministerium für Gesundheit, Arbeit und Wohlfahrt gestellt habe. Taiho Pharmaceutical bemüht sich um die Zulassung von TAS-102 für die Indikation des inoperablen, rezidivierenden kolorektalen Karzinoms.

Der Zulassungsantrag beruht auf den Ergebnissen einer klinischen Phase-II-Studie (Studie 10040030), die an 20 Einrichtungen in ganz Japan durchgeführt wurde. Dabei handelte es sich um eine randomisierte Doppelblind-Vergleichsstudie von TAS-102 und einem Placebo an 172 Patienten mit inoperablen, rezidivierenden kolorektalen Karzinomen im fortgeschrittenen Stadium, die für herkömmliche Chemotherapie unempfänglich sind und mindestens zweimal oder häufiger mit Fluoropyrimidin, Irinotecan und Oxaliplatin behandelt wurden. Die Ergebnisse zeigten, dass die mit TAS-102 behandelte Gruppe eine verbesserte Gesamtüberlebensrate (mittleres Gesamtüberleben: 9,0 Monate vs. 6,6 Monate) und ein deutlich reduziertes Sterberisiko (HR: 0,56, p=0,0011) aufwies. Die am häufigsten berichtete Arzneimittelnebenwirkung mit einem CTCAE-Wert von 3 oder höher war Neutropenie. Durchfall, Müdigkeit, Übelkeit und sonstige Nebenwirkungen der Klasse 3 lagen nicht über 10 %. In einer ähnlichen Patientengruppe führt Taiho Pharmaceutical derzeit eine globale klinische Phase-III-Studie von TAS-102 bei kolorektalen Karzinomen (RECOURSE) durch. Das oberste Ziel besteht in der globalen Registrierung und Vermarktung des Wirkstoffs.

Taiho Pharmaceutical ist der Ansicht, dass TAS-102 einen signifikanten
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SOURCE Taiho Pharmaceutical Co., Ltd.
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