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FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen.
Barone, Amy; Chi, Dow-Chung; Theoret, Marc R; Chen, Huanyu; He, Kun; Kufrin, Dubravka; Helms, Whitney S; Subramaniam, Sriram; Zhao, Hong; Patel, Anuja; Goldberg, Kirsten B; Keegan, Patricia; Pazdur, Richard.
Afiliação
  • Barone A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. amy.barone@fda.hhs.gov.
  • Chi DC; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Theoret MR; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Chen H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • He K; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Kufrin D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Helms WS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Subramaniam S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zhao H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Patel A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Goldberg KB; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Keegan P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 23(24): 7448-7453, 2017 Dec 15.
Article em En | MEDLINE | ID: mdl-28774898

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tetra-Hidroisoquinolinas / Dioxóis / Leiomiossarcoma / Lipossarcoma / Cardiomiopatias Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2017 Tipo de documento: Article País de publicação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tetra-Hidroisoquinolinas / Dioxóis / Leiomiossarcoma / Lipossarcoma / Cardiomiopatias Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2017 Tipo de documento: Article País de publicação: Estados Unidos