# Lazertinib

Lazertinib (Lazcluze, Janssen Cilag International NV) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: EGFR (1).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| EGFR exon 19 deletions or exon 21 L858R | + amivantamab | 1st line, advanced | - |

## Products

### Lazcluze

- Company: Janssen Cilag International NV
- Target: EGFR tyrosine kinase inhibitor
- Class: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
- ATC: L01EB09
- EU approval: 20 Jan 2025
- Label revised: 12 Oct 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/lazcluze-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/lazcluze-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/lazcluze

Mechanism (SmPC section 5.1): Lazertinib is an irreversible EGFR tyrosine kinase inhibitor that selectively inhibits primary activating EGFR mutations and the T790M resistance mutation.

## Label wording

- **Lazertinib** (Lazcluze), Non-small cell lung cancer, 1st line, advanced: “Lazcluze in combination with amivantamab is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lazcluze-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/lazertinib