Drug updated on 5/17/2024
Dosage Form | Capsules (oral; 50 mg, 150 mg, and 200 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
- Indicated for the treatment of adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.
- Indicated for the treatment of pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.
Latest News
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Summary
- Nilotinib (Tasigna) is indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase, as well as those resistant to or intolerant of prior therapy that included imatinib.
- Four systematic reviews/meta-analyses provided information on Tasigna's safety and effectiveness compared to other tyrosine kinase inhibitors such as dasatinib, imatinib, bosutinib, ponatinib, and radotinib in treating chronic myeloid leukemia.
- The first study found Nilotinib has a lower prevalence of anemia, neutropenia, and thrombocytopenia compared to dasatinib. This suggests that Nilotinib may have a safer hematological profile, particularly when compared with dasatinib.
- However, the second study highlighted concerns about an increased risk of cardiovascular adverse events including coronary artery disease (CAD), acute coronary syndrome (ACS), cerebrovascular accidents (CVA), peripheral artery occlusive disease (PAOD), and arrhythmias when using Nilotinib, especially when comparing it against imatinib.
- The third study suggested limited data but potentially better overall survival outcomes post-allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with Ph+ acute lymphoblastic leukemia (ALL). It was noted this was more prevalent among patients who had minimal residual disease (MRD)-positive status while using second-generation TKIs like dasatinib and Nilotinib over the first-generation TKI imatinib.
- The fourth study showed through network meta-analysis aimed at comparing safety among various TKIs that dasatinib presents the highest risk for serious hematological adverse events whereas Nilotinib appears safer according to the Surface Under Cumulative Ranking curve (SUCRA) values for different adverse events. However, this analysis did not address non-hematological toxicities.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tasigna (nilotinib) Prescribing Information. | 2024 | Novartis Pharmaceuticals Corporation, East Hanover, New Jersey |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Hematological adverse events with tyrosine kinase inhibitors for chronic myeloid leukemia: a systematic review with meta-analysis. | 2023 | Cancers |
Cardiovascular adverse events in chronic myeloid leukemia patients treated with nilotinib or imatinib: a systematic review, meta-analysis and integrative bioinformatics analysis. | 2022 | Frontiers in Cardiovascular Medicine |
Relapse prevention with tyrosine kinase inhibitors after allogeneic transplantation for Philadelphia chromosome-positive acute lymphoblast leukemia: a systematic review. | 2020 | Biology of Blood and Marrow Transplantation |
Haematological adverse events associated with tyrosine kinase inhibitors in chronic myeloid leukaemia: a network meta-analysis. | 2019 | British Journal of Clinical Pharmacology |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Management of chronic myeloid leukemia in children and young adults. | 2022 | Current Hematologic Malignancy Reports |
A practical guide to managing hypertension, hyperlipidemia, and hyperglycemia in patients with chronic myeloid leukemia. | 2022 | Frontiers in Medicine |
Chronic myeloid leukemia, version 2.2021. | 2020 | Journal of the National Comprehensive Network of Cancer |
A British Society for Haematology Guideline on the diagnosis and management of chronic myeloid leukaemia. | 2020 | British Journal of Haematology |
Acute lymphoblastic leukemia, version 2.2021. | 2020 | Journal of the National Comprehensive Network of Cancer |