Summary

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• Sprycel (dasatinib) is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase; for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib; for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy; for the treatment of pediatric patients 1 year of age and older with Ph+ CML in the chronic phase; and for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.
• This summary is based on the review of seven systematic review(s)/meta-analysis(es). ^[1-7]
• Effectiveness in Pediatric Ph+ALL: Dasatinib demonstrated superior overall survival (OS) and event-free survival (EFS) compared to imatinib in pediatric patients with Ph+ALL, with hazard ratios of 2.26 for OS and 2.36 for EFS.
• Post-allogeneic Hematopoietic Stem Cell Transplantation: Maintenance therapy with dasatinib post-transplant in Ph+ALL patients resulted in high overall survival (87%-100%) and disease-free survival rates (89%-100%).
• Comparison with Imatinib and Other Second-generation TKIs: Dasatinib generally showed superior or comparable effectiveness to imatinib and other second-generation TKIs, with better molecular response rates but a higher incidence of hematological adverse events.
• Hematological Adverse Events (AEs): Dasatinib demonstrated a higher prevalence of anemia (54.5%), neutropenia (51.2%), and thrombocytopenia (62.2%) compared to other tyrosine kinase inhibitors (TKIs). The relative risks (RR) were notably higher compared to imatinib, with odds ratios (OR) of 1.65 for anemia, 1.72 for neutropenia, and 2.04 for thrombocytopenia.
• Hepatotoxicity: Dasatinib did not exhibit a significantly increased risk of hepatotoxicity when compared with other second-generation TKIs, such as bosutinib and nilotinib.