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FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation.
Woods, Ashley; Norsworthy, Kelly J; Wang, Xin; Vallejo, Jonathon; Chiu Yuen Chow, Edwin; Li, Ruo-Jing; Sun, Jielin; Charlab, Rosane; Jiang, Xiling; Pazdur, Richard; Theoret, Marc R; de Claro, R Angelo.
Afiliación
  • Woods A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Norsworthy KJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Wang X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Vallejo J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Chiu Yuen Chow E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Li RJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Sun J; 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.
  • Jiang X; 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.
  • Theoret MR; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • de Claro RA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 30(7): 1226-1231, 2024 Apr 01.
Article en En | MEDLINE | ID: mdl-38010220
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Piridinas / Azacitidina / Leucemia Mieloide Aguda / Glicina Límite: Aged / Humans Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article
Texto completo
Imprimir
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Piridinas / Azacitidina / Leucemia Mieloide Aguda / Glicina Límite: Aged / Humans Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article