Phenotype-Specific Safety Differences Between Gilteritinib and Midostaurin in AML: A FAERS Analysis Highlighting Differentiation Syndrome Signal (SOHO 2026) - Sep 1, 2026 - Abstract #AML-103; Location: LEVEL 3, HALL B3; "In this AML-restricted FAERS analysis, gilteritinib and midostaurin demonstrated comparable overall cardiac safety signals, with a nonsignificant trend toward increased QT prolongation with gilteritinib. A marked disproportionality signal for differentiation syndrome with gilteritinib represents the most clinically relevant safety difference between agents. These findings highlight distinct phenotype-specific safety patterns and support phenotype-directed monitoring strategies, while underscoring the need for confirmatory studies using controlled data sources, as these observations are hypothesis-generating."
Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3
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Edward Mwarangu MD,MSc,MBA 1; Nahid Suleman MD 2
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