# Lazertinib

Source: https://onco.cc/drugs/lazertinib/  
OnCo record `lazertinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-06
- Brand: Lazcluze
- Modality: Small-molecule kinase inhibitor (EGFR)
- Mechanism: Irreversible mutant-selective EGFR TKI (exon 19 del, L858R, T790M), CNS-penetrant.
- Approvals: US 2024: First-line EGFR exon 19 del / L858R NSCLC with amivantamab; EU 2025: 1L EGFR-mutant NSCLC with amivantamab; 20 Jan 2025; England (NICE) 2026: Untreated advanced EGFR mutation-positive non-small-cell lung cancer (exon 19 deletion or L858R), with amivantamab

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Lazertinib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Lazertinib
- NICE TA1122: amivantamab with lazertinib for untreated EGFR mutation-positive advanced non-small-cell lung cancer: https://www.nice.org.uk/guidance/ta1122

## Connected records

- biomarkers: [EGFR exon 19 deletion](https://onco.cc/biomarkers/egfr-exon-19-deletion/), [EGFR L858R](https://onco.cc/biomarkers/egfr-l858r/)
- cancers: [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- drugs: [Amivantamab](https://onco.cc/drugs/amivantamab/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- trials: [A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure](https://onco.cc/trials/nct04988295/), [A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)](https://onco.cc/trials/nct06667076/), [A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer](https://onco.cc/trials/nct05498428/), [A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)](https://onco.cc/trials/nct05388669/), [A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC](https://onco.cc/trials/nct07586202/), [CHRYSALIS](https://onco.cc/trials/chrysalis/), [Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib](https://onco.cc/trials/nct06120140/), [MARIPOSA](https://onco.cc/trials/mariposa/), [Premedication to Reduce Amivantamab Associated Infusion Related Reactions](https://onco.cc/trials/nct05663866/), [To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation](https://onco.cc/trials/nct05541822/)
- terms: [EGFR exon 19 deletion & L858R](https://onco.cc/terms/egfr-exon19-l858r/), [Lung cancer drugs in England: what NICE has recommended](https://onco.cc/terms/lung-uk-drug-access/)
- pairings: [Amivantamab + lazertinib (first-line EGFR NSCLC)](https://onco.cc/pairings/amivantamab-plus-lazertinib/)
- people: [Byoung Chul Cho](https://onco.cc/people/cho-byoung-chul/), [Dae Ho Lee](https://onco.cc/people/lee-dae-ho/)
- key papers: [MARIPOSA: amivantamab plus lazertinib versus osimertinib as first treatment for EGFR-mutated lung cancer](https://onco.cc/key-papers/paper-mariposa-nejm-2024/)
- pathways: [Drug-tolerant persister cells](https://onco.cc/pathways/drug-tolerant-persisters/), [Non-small cell lung cancer (KEGG map)](https://onco.cc/pathways/nsclc-signalling/)
- roadmaps: [Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall](https://onco.cc/roadmaps/targeted-therapy-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/lazertinib.json