Drug updated on 4/16/2024
| 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
- For the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in 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 chronic phase.
- For the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.
Summary
- Dasatinib (Sprycel) is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, and also for those with resistance or intolerance to prior therapy including imatinib.
- The drug is also used in treating pediatric patients aged 1 year and older with Ph+ CML in chronic phase, as well as those newly diagnosed with Ph+ acute lymphoblastic leukemia (ALL), when combined with chemotherapy.
- A systematic review and meta-analysis showed that dasatinib was superior to imatinib in improving overall survival rates and event-free survival rates among pediatric patients suffering from Ph+ ALL when combined with chemotherapy.
- Another systematic review comparing second-generation tyrosine kinase inhibitors nilotinib and dasatinib against first-generation TKI imatinb revealed that use of these drugs after allogeneic hematopoietic stem cell transplantation improved overall survival especially among minimal residual disease positive status patients; however, data on newer generation TKIs were limited requiring further study through large randomized clinical trials.
- In a network meta-analysis involving six different tyrosine kinase inhibitors including dasatnibi at 12 months follow-up period, it was found that while Imantinb had the safest profile but low efficacy; Nilotinb emerged as most effective but lacked safety data at this time point suggesting need for cost-effectiveness analyses incorporating new TKIs like ponatanbi etc., 6. These findings are based on three documents which include Systematic Reviews / Meta-Analyses providing insights into comparative effectiveness of various Tyrosine Kinase Inhibitors including Dasatnibi(Sprycel).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Sprycel (dasatinib) Prescribing Information. | 2023 | Bristol-Myers Squibb Company, Princeton, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Use of tyrosine kinase inhibitors for paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia: a systematic review and meta-analysis. | 2021 | BMJ Journals |
| Relapse prevention with tyrosine kinase inhibitors after allogeneic transplantation for Philadelphia chromosome-positive acute lymphoblast leukemia: a systematic review. | 2019 | Biology of Blood and Marrow Transplantation |
| Comparative efficacy and safety of tyrosine kinase inhibitors for chronic myeloid leukaemia: a systematic review and network meta-analysis. | 2018 | European Journal of Cancer |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| 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 |