Class/mechanism: Tyrosine kinase inhibitor of Bcr-Abl, the constitutively active tyrosine kinase resulting from the Philadelphia chromosome abnormality in CML. Nilotinib binds to the inactive conformation of the Abl kinase domain and stabilizes it.
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Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 10/29/2007: Granted accelerated approval for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included Imatinib (Gleevec).
- 6/17/2010: Granted accelerated approval for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (Approval extended to first-line setting)
- 12/22/2017: FDA label updated: Patients with newly diagnosed Ph+ CML in the chronic phase (CP) and resistant or intolerant Ph+ CML-CP patients who have achieved a sustained molecular response (MR4.5) may be considered for discontinuation after at least three years of nilotinib. To be considered for discontinuation, patients must have typical BCR-ABL transcripts. An FDA-authorized test with a detection limit below at least MR4.5 must be used to determine discontinuation eligibility. Patients must be frequently monitored by this test to detect possible loss of remission.
- 3/22/2018: FDA approved for pediatric patients 1 year of age or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. (Approval extended to pediatric setting)
Also known as
- Code name: AMN107
- Brand name: Tasigna