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 of Lazertinib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer1
EGFR exon 19 deletions or exon 21 L858R
+ amivantamab
1L
advanced
None
Full text of section 4.1 (therapeutic indications)

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.

Label history

4 changes to the Lazcluze label since 2025, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes