Journal of Blood Medicine
Comparative Outcomes of Generic and Branded Dasatinib in Chronic-Phase Chronic Myeloid Leukemia: A Single-Center Within-Patient Analysis
By Anas Mohamed Babiker, Elrazi Ali, Alaa Abdullah Ali Rahhal and 4 others.
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.