Drug updated on 4/17/2024
| Dosage Form | Capsules (oral; 50 mg, 150 mg, and 200 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- 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.
- 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.
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 or intolerant to prior therapy that included imatinib.
- Three systematic reviews/meta-analyses were reviewed which provided insights into the safety and efficacy of nilotinib (Tasigna).
- The first study reveals that patients treated with nilotinib have a higher risk of cardiovascular adverse events compared to those treated with imatinib, particularly when used as a first-line treatment; however, no significant difference was found in the risk of heart failure between these two groups.
- According to the second study, while different doses of nilotinib showed favorable tolerability and safety profiles among Parkinson's disease patients, its clinical effectiveness was not superior based on motor outcomes despite some improvement observed in cerebrospinal fluid biomarker levels at 300 mg dosage.
- In terms of treating CML specifically, an analysis presented in a third study suggests that overall efficacy is superior for nilotinib compared to other tyrosine kinase inhibitors such as dasatinbimutnubosutatradoniponati; however it also notes lack data regarding its safety profile at 12 months.
- Despite this potential advantage over other treatments for CML noted above, further cost-effectiveness analyses are recommended due considering inclusion new TKI like ponatinibradoti according last document reviewed.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Tasigna (nilotinib) Prescribing Information. | 2021 |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| 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 |
| Nilotinib in Parkinson's disease : a systematic review and meta-analysis. | 2022 | Frontiers In Aging Neuroscience |
| 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. | 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 |