Lazcluze lazertinib

Drug Class

EGFR tyrosine kinase inhibitor

Mechanism

Inhibits EGFR tyrosine kinase activity, targeting both activating EGFR mutations (exon 19 deletion and L858R) and resistance mutations (T790M).

Approved Indication

In combination with amivantamab for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R substitution mutations, per its FDA approval.

What This Means For Patients

Lazcluze is a third-generation EGFR inhibitor used in combination with amivantamab (Rybrevant) as a first-line treatment for advanced non-small cell lung cancer with specific EGFR mutations. It targets genetic aberrations while crossing the blood-brain barrier to treat brain metastases, and is accessible in Boao Lecheng.

Regulatory Approvals

• FDA — approved (2024) — source

Pivotal Clinical Evidence

• MARIPOSA — Yang et al., N Engl J Med 2025 (NCT04487080) — DOI

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-lazertinib-egfr-mutated-advanced-nsclc
• https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218268