Nilotinib
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.
- Medicare
- Part D (self-administered)
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.
- Commercial insurance
- step therapy common
Generic imatinib first is a common commercial requirement; generic nilotinib preferred over Tasigna.
- Assistance programmes
- Novartis Patient Support (Patient Assistance NOW Oncology)
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- Appraised for
- Untreated chronic phase CML (dasatinib, nilotinib and standard-dose imatinib)
- Notes
- After imatinib: TA241 (2012) and TA426 (2016).
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA251 · SMC advice: nilotinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| 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 |
Trials
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Latest papers
topQuery 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.
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