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FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma.
Chang, Elaine; Weinstock, Chana; Zhang, Lijun; Charlab, Rosane; Dorff, Sarah E; Gong, Yutao; Hsu, Vicky; Li, Fang; Ricks, Tiffany K; Song, Pengfei; Tang, Shenghui; Waldron, Peter E; Yu, Jingyu; Zahalka, Eias; Goldberg, Kirsten B; Pazdur, Richard; Theoret, Marc R; Ibrahim, Amna; Beaver, Julia A.
Afiliação
  • Chang E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. elaine.chang@fda.hhs.gov.
  • Weinstock C; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zhang L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Charlab R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Dorff SE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gong Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Hsu V; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Li F; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Song P; 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.
  • Waldron PE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zahalka E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Goldberg KB; Oncology Center of Excellence, 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.
  • Theoret MR; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ibrahim A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Beaver JA; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 27(4): 922-927, 2021 02 15.
Article em En | MEDLINE | ID: mdl-32962979
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias da Bexiga Urinária / Carcinoma de Células de Transição / Aprovação de Drogas / Anticorpos Monoclonais Tipo de estudo: Clinical_trials / Diagnostic_studies / Prognostic_studies Limite: Humans País como assunto: America do norte Idioma: En Ano de publicação: 2021 Tipo de documento: Article
Texto completo
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PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias da Bexiga Urinária / Carcinoma de Células de Transição / Aprovação de Drogas / Anticorpos Monoclonais Tipo de estudo: Clinical_trials / Diagnostic_studies / Prognostic_studies Limite: Humans País como assunto: America do norte Idioma: En Ano de publicação: 2021 Tipo de documento: Article