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Taiho Pharmaceutical presenta una solicitud para fabricar y comercializar el nuevo agente antitumoral TAS-102
Date:2/26/2013

TOKIO, 27 de febrero de 2013 /PRNewswire/ -- Taiho Pharmaceutical Co., Ltd. anunció el 27 de febrero haber presentado una solicitud el día 26 de febrero para la aprobación de la fabricación y marketing del nuevo agente antitumoral nucleósido oral  TAS-102 (combinación de trifluorothymidine (FTD) y tipiracil hydrochloride (TPI)) al Ministerio de Salud , Trabajo y Bienestar de Japón. Taiho Pharmaceutical busca la aprobación de TAS-102 para la indicación de cáncer colorrectal no reseccionable, avanzado y recurrente.  

La solicitud de aprobación se basa en los resultados de un ensayo clínico de fase II (estudio 10040030) realizado en 20 plantas en Japón. Fue un estudio comparativo y de doble ciego de TAS-102 y placebo que reclutó a 172 pacientes con cáncer colorrectal no reseccionable, avanzado y recurrente que fue refractario para la quimioterapia estándar de al menos dos o más regímenes con fluoropyrimidine, irinotecan y oxaliplatin. Los resultados indicaron que el grupo que administró TAS-102 había mejorado las tasas de supervivencia generales (supervivencia general media: 9,0 meses vs. 6,6 meses) y un riesgo significativamente reducido de mortalidad (HR: 0,56, p=0,0011). La reacción secundaria del fármaco más frecuentemente notificada con un grado CTCAE de 3 o más fue neutropenia. La diarrea de grado 3 o superior, la fatiga, náuseas y otras reacciones secundarias no fueron más del 10%. Taiho Pharmaceutical está actualmente procediendo con un ensayo clínico de fase III global de TAS-102 en una población de cáncer colorrectal similar (RECOURSE) con el objetivo final de registro y comercialización global del agente.  

Taiho Pharmaceutical cree que TAS-102 realizará una contribución significativa para los pacientes c
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SOURCE Taiho Pharmaceutical Co., Ltd.
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