Article
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.
Clinical cancer research : an official journal of the American Association for Cancer Research - 15 Aug 2020
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
Abstract excerpt
PURPOSE: Differentiation syndrome (DS) is a serious adverse reaction of isocitrate dehydrogenase (IDH) inhibitors ivosidenib and enasidenib in patients with (IDH)1- and IDH2-mutated acute myeloid leukemia (AML), respectively. EXPERIMENTAL DESIGN: During FDA review of marketing applications for ivosidenib and enasidenib, data from pivotal trials were queried to identify cases of DS in patients with relapsed or...
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