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FDA Approval Summary: Ado-Trastuzumab Emtansine for the Adjuvant Treatment of HER2-positive Early Breast Cancer.
Wedam, Suparna; Fashoyin-Aje, Lola; Gao, Xin; Bloomquist, Erik; Tang, Shenghui; Sridhara, Rajeshwari; Goldberg, Kirsten B; King-Kallimanis, Bellinda L; Theoret, Marc R; Ibrahim, Amna; Amiri-Kordestani, Laleh; Pazdur, Richard; Beaver, Julia A.
Afiliação
  • Wedam S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. Suparna.Wedam@fda.hhs.gov.
  • Fashoyin-Aje L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gao X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Bloomquist E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Sridhara R; 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.
  • King-Kallimanis BL; Oncology Center of Excellence, 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.
  • Ibrahim A; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Amiri-Kordestani L; 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.
  • Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 26(16): 4180-4185, 2020 08 15.
Article em En | MEDLINE | ID: mdl-32217612

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Limite: Adult / Aged / Aged80 / Female / Humans / Middle aged País/Região como assunto: America do norte Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Limite: Adult / Aged / Aged80 / Female / Humans / Middle aged País/Região como assunto: America do norte Idioma: En Ano de publicação: 2020 Tipo de documento: Article