ArticleJournal of blood medicine2026
Comparative Outcomes of Generic and Branded Dasatinib in Chronic-Phase Chronic Myeloid Leukemia: A Single-Center Within-Patient Analysis.
Article in Journal of blood medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors.
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Abstract
Background: Tyrosine kinase inhibitors (TKIs) have transformed chronic myeloid leukaemia (CML) from a fatal malignancy into a manageable chronic condition. Second-generation TKIs, including dasatinib, achieve faster, deeper molecular responses and overcome imatinib resistance or intolerance. However, high acquisition costs limit access, particularly in resource-constrained settings. The FDA approval of generic dasatinib in September 2024 represents a landmark step towards affordability. Methods: A retrospective, single-center, within-patient paired cohort study, paired before-after design was conducted at the National Center for Cancer Care and Research in Qatar. A 58 adults patients with confirmed chronic-phase CML (CP-CML) who transitioned from branded Sprycel Results: Fifty-eight patients were included (mean follow-up 6 months). Complete hematologic response was achieved (maintained) in all patients (100%); major molecular response in 56 (96.6%). No grade 3-4 adverse events occurred. Overall adverse-event rates were comparable between formulations (15.5% vs 13.8%; P = 1.000). During the follow-up period, toxicity-related hospitalizations were numerically lower with generic dasatinib but not statistically significant (1.7% vs 10.3%; P = 0.063). A statistically significant but clinically modest platelet count increase was observed post-switch (211.5 ± 64.9 vs 233.8 ± 95.4×10 Conclusion: Despite the primary limitation of a small sample size and short follow up period, generic dasatinib formulation, demonstrated short-term safety and efficacy comparable to those of the branded formulation. High response rates, favorable tolerability, and fewer hospitalizations were observed, supporting its potential as a more cost-accessible treatment option. However, these findings should be interpreted cautiously, and larger, multicenter prospective studies with longer follow-up are needed to confirm comparative effectiveness, safety, and long-term clinical outcomes.
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