Nilotinib

(Tasigna®)

Tasigna®

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Drug updated on 5/17/2024

Dosage FormCapsules (oral; 50 mg, 150 mg, and 200 mg)
Drug ClassKinase 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.

Summary
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  • 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 TitleYearSource
Tasigna (nilotinib) Prescribing Information.2024Novartis Pharmaceuticals Corporation, East Hanover, New Jersey

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines