Phenotype-Specific Safety Reporting Signals of Asciminib Versus Second- and Third-Generation Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia: A FAERS Disproportionality Analysis (SOHO 2026) - Sep 1, 2026 - Abstract #CML-115; Location: LEVEL 3, HALL B3; "Asciminib was compared with dasatinib, nilotinib, bosutinib, and ponatinib. In FAERS ICSRs restricted to CML and primary suspect drugs, asciminib showed a consistent pattern of disproportionate reporting across multiple prespecified toxicity domains and death outcomes compared with pooled second- and third-generation TKIs. Because ICSRs lack exposure denominators and are subject to underreporting, selective reporting, and confounding by indication, these findings should be interpreted as hypothesis-generating signals that prioritize validation in controlled real-world datasets with exposure adjustment and clinical adjudication and may inform phenotype-directed monitoring while confirmatory analyses are pursued."
Clinical • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology
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Edward Mwarangu MD,MSc,MBA 1; Nahid Suleman MD 2
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