OnCo
drugsProductNot mapped hereapproved

Ceritinib

Ceritinib is a second-generation ALK pill for lung cancer, effective after crizotinib but with gastrointestinal toxicity that limited uptake.

ASCEND-1/2/5 after crizotinib; ASCEND-4 first line versus chemotherapy (PFS 16.6 vs 8.1 months). Approved 2014 (accelerated) and 2017 first line; 450 mg with food improved tolerability. Rarely used now versus alectinib, brigatinib, lorlatinib.

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Ceritinib
PubChem
Modality
Small-molecule ALK TKI (second generation)
Mechanism
Potent ALK inhibitor active against several crizotinib-resistance mutations (L1196M, G1269A, I1171T, S1206Y).
Brand / code
Zykadia
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).

Commercial insurance
covered with prior authorisation

Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.

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.

NICE recommendedNICE TA500 · 2018SMC: accepted
Appraised for
Untreated ALK-positive advanced NSCLC
Notes
After crizotinib: TA395 (2016).
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA500 · SMC advice: ceritinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2014ALK-positive metastatic NSCLC after crizotinib
US2017First-line ALK-positive metastatic NSCLC

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Ceritinib
intervention: Ceritinib
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Ceritinib" OR ABSTRACT:"Ceritinib" OR TITLE:"Zykadia" OR ABSTRACT:"Zykadia") 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 Ceritinib, not a curated reading list.

Connected

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