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FDA Approval Summary: Glasdegib for Newly Diagnosed Acute Myeloid Leukemia.
Norsworthy, Kelly J; By, Kunthel; Subramaniam, Sriram; Zhuang, Luning; Del Valle, Pedro L; Przepiorka, Donna; Shen, Yuan-Li; Sheth, Christopher M; Liu, Chao; Leong, Ruby; Goldberg, Kirsten B; Farrell, Ann T; Pazdur, Richard.
Afiliación
  • Norsworthy KJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. Kelly.Norsworthy@fda.hhs.gov.
  • By K; 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.
  • Zhuang L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Del Valle PL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Przepiorka D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Shen YL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Sheth CM; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Liu C; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Leong R; 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.
  • Farrell AT; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 25(20): 6021-6025, 2019 10 15.
Article en En | MEDLINE | ID: mdl-31064779

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Compuestos de Fenilurea / Bencimidazoles / Leucemia Mieloide Aguda / Aprobación de Drogas / Citarabina / Antineoplásicos Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: America do norte Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2019 Tipo del documento: Article

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Compuestos de Fenilurea / Bencimidazoles / Leucemia Mieloide Aguda / Aprobación de Drogas / Citarabina / Antineoplásicos Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: America do norte Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2019 Tipo del documento: Article