The European Medicines Agency Review of Tegafur/Gimeracil/Oteracil (Teysuno™) for the Treatment of Advanced Gastric Cancer When Given in Combination with Cisplatin: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use (CHMP)

The product Teysuno™ (S-1) contains tegafur, a prodrug of 5-fluorouracil (5-FU), and two modulators of 5-FU metabolism, gimeracil and oteracil. The main clinical study in this application was a randomized controlled study comparing S-1 plus cisplatin with 5-FU plus cisplatin. In this study, median o...

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Detalhes bibliográficos
Main Authors: Matt, Petra, van Zwieten-Boot, Barbara, Calvo Rojas, Gonzalo, ter Hofstede, Hadewych, Garcia-Carbonero, Rocio, Camarero, Jorge, Abadie, Eric, Pignatti, Francesco
Formato: Artigo
Idioma:Inglês
Publicado em: AlphaMed Press 2011
Assuntos:
Regulatory Issues: EMA
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3228070/
https://ncbi.nlm.nih.gov/pubmed/21963999
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2011-0224
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