Loading
Nilotinib is a second-generation CML pill that produces deeper responses faster than imatinib, at the cost of cardiovascular and metabolic side effects.
Approved in 2007 for imatinib-resistant CML and in 2010 first line (ENESTnd: higher major molecular response than imatinib without an overall survival difference). Requires fasting dosing, QT monitoring and attention to arterial occlusive events, hyperglycaemia and lipids. Widely used as the bridge to treatment-free remission because of deep responses; generic since 2024 in some markets.
ATP-competitive inhibitor of BCR-ABL1 with ~30-fold greater potency than imatinib; also KIT, PDGFR. Connects to BCR::ABL1 (Philadelphia chromosome) and KIT.
1.Nilotinib slips into a pocket on BCR::ABL1 (Philadelphia chromosome).
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). Generic nilotinib is available; Danziten (nilotinib tartrate) is a newer branded formulation.
Generic imatinib first is a common commercial requirement; generic nilotinib preferred over Tasigna.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA251 · SMC advice: nilotinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Chronic phase and accelerated phase Philadelphia chromosome positive CML in adults resistant or intolerant to prior therapy that included Gleevec (imatinib)
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Newly diagnosed adults with with Philadelphia chromosome-positive CML in chronic phase
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Chronic phase and accelerated phase Philadelphia chromosome positive CML in adults resistant or intolerant to prior therapy that included Gleevec (imatinib)
Confirmed: the accelerated approval of 2007 converted to traditional approval 3.2 years after it was granted.
Newly diagnosed adults with with Philadelphia chromosome-positive CML in chronic phase
Confirmed: the accelerated approval of 2010 converted to traditional approval 4.6 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 2007 | Ph+ CML, chronic or accelerated phase, resistant/intolerant to imatinib |
| US | 2010 | Newly diagnosed Ph+ CML chronic phase |
| EU | 2007 | Ph+ CML |
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Query for this drug: (TITLE:"Nilotinib" OR ABSTRACT:"Nilotinib" OR TITLE:"Tasigna" OR ABSTRACT:"Tasigna") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Nilotinib, not a curated reading list.
Shares A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP), A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP, Sokal and ELTS risk scores (chronic myeloid leukaemia), BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR).
Shares A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP, Sokal and ELTS risk scores (chronic myeloid leukaemia), BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), BCR::ABL1 kinase domain mutations (T315I and others).
Shares A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP, Sokal and ELTS risk scores (chronic myeloid leukaemia), BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), IRIS: imatinib versus interferon plus cytarabine as first treatment for chronic myeloid leukaemia.
Shares BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), BCR::ABL1 kinase domain mutations (T315I and others), Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia, accelerated and blast phase.
Shares BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (KEGG map), Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia, accelerated and blast phase.
Shares BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), BCR::ABL1 kinase domain mutations (T315I and others), BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (KEGG map).
Shares Sokal and ELTS risk scores (chronic myeloid leukaemia), BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), Molecular response (MMR, MR4, treatment-free remission), BCR::ABL1 kinase domain mutations (T315I and others).
Shares IRIS: imatinib versus interferon plus cytarabine as first treatment for chronic myeloid leukaemia, Chronic myeloid leukaemia, chronic phase, BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).