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Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis.
Norsworthy, Kelly J; Mulkey, Flora; Scott, Emma C; Ward, Ashley F; Przepiorka, Donna; Charlab, Rosane; Dorff, Sarah E; Deisseroth, Albert; Kazandjian, Dickran; Sridhara, Rajeshwari; Beaver, Julia A; Farrell, Ann T; de Claro, R Angelo; Pazdur, Richard.
Affiliation
  • Norsworthy KJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. kelly.norsworthy@fda.hhs.gov.
  • Mulkey F; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Scott EC; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ward AF; 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.
  • 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.
  • Deisseroth A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Kazandjian D; 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.
  • Beaver JA; Center for Drug Evaluation and Research, 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.
  • de Claro RA; 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 ; 26(16): 4280-4288, 2020 08 15.
Article de En | MEDLINE | ID: mdl-32393603

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Leucémie aigüe myéloïde / Isocitrate dehydrogenases Type d'étude: Diagnostic_studies / Prognostic_studies Limites: Humans Pays/Région comme sujet: America do norte Langue: En Journal: Clin Cancer Res Sujet du journal: NEOPLASIAS Année: 2020 Type de document: Article Pays de publication: États-Unis d'Amérique

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Leucémie aigüe myéloïde / Isocitrate dehydrogenases Type d'étude: Diagnostic_studies / Prognostic_studies Limites: Humans Pays/Région comme sujet: America do norte Langue: En Journal: Clin Cancer Res Sujet du journal: NEOPLASIAS Année: 2020 Type de document: Article Pays de publication: États-Unis d'Amérique