Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
- Indicated 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.
- Indicated for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
- Indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase.
- Indicated for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.
Latest News
Summary
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Sprycel (dasatinib) Prescribing Information. | 2023 | Bristol-Myers Squibb Company, Princeton, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Management of chronic myeloid leukemia in children and young adults. | 2022 | Current Hematologic Malignancy Reports |
A clinician perspective on the treatment of chronic myeloid leukemia in the chronic phase. | 2022 | Journal of Hematology & Oncology |
Chronic myeloid leukemia, version 2.2021, NCCN clinical practice guidelines in oncology. | 2021 | Journal of National Comprehensive Cancer |
Acute lymphoblastic leukemia, version 2.2021, NCCN clinical practice guidelines in oncology. | 2021 | Journal of National Comprehensive Cancer |
JSH practical guidelines for hematological malignancies, 2018: I. Leukemia-4. chronic myeloid leukemia. (cml)/myeloproliferative neoplasms (MPN). | 2020 | International Journal of Hematology |