Comparative Outcomes of Generic and Branded Dasatinib in Chronic-Phase Chronic Myeloid Leukemia: A Single-Center Within-Patient Analysis.

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^®(dasatinib) to Daleubin^® (dasatinib) between January 2024 and December 2025 were included. Primary outcomes were hematologic and major molecular response rates. Secondary outcomes included adverse events, adherence, dose modifications, and toxicity-related hospitalizations. Paired t-tests and McNemar's exact test were applied. .

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 ± 95.4×10⁹/L; P = 0.046). .

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.