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.

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Title: 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.
Authors: 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.
Source: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2020 Aug 15; Vol. 26 (16), pp. 4280-4288. Date of Electronic Publication: 2020 May 11.
Publication Type: Journal Article; Research Support, U.S. Gov't, Non-P.H.S.; Research Support, U.S. Gov't, P.H.S.; Comment
Journal Info: Publisher: American Association for Cancer Research Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1557-3265
DOI:10.1158/1078-0432.CCR-20-0834