OnCo
drugsProductApproved2024🇪🇺🇬🇧🇯🇵🇨🇳

Lazertinib

A third-generation EGFR pill used together with amivantamab as the first regimen to beat osimertinib in EGFR-mutant lung cancer.

Developed by Yuhan, licensed to Janssen. Approved August 2024 only in combination with amivantamab (MARIPOSA: PFS HR 0.70; OS HR 0.75 with median >12 months longer than osimertinib, 2025). Rash, paronychia, and venous thromboembolism (prophylactic anticoagulation for 4 months) are the combination's main burdens.

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Lazertinib
PubChem
Modality
Small-molecule kinase inhibitor (EGFR)
Mechanism
Irreversible mutant-selective EGFR TKI (exon 19 del, L858R, T790M), CNS-penetrant.
Brand / code
Lazcluze
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). Lazcluze is oral and Part D; its partner amivantamab is an infusion under Part B, so a patient on the MARIPOSA regimen pays under both benefits.

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.

Not yet researchedSearch NICE
Notes
MHRA-licensed 2025 with amivantamab (MARIPOSA); NICE appraisal in progress.

Sources: NICE search: lazertinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2024First-line EGFR exon 19 del / L858R NSCLC with amivantamab

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
30 studies9 recruiting26 Phase 24 Phase 3
Search “Lazertinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

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

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Landmark trials in OnCo

Latest papers

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Literature trend72 papers in the last 12 months+4% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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

Connected

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