Characterizing the post-market safety profile of lazertinib: a pharmacovigilance study of the FDA Adverse Events...

Lazertinib is a third-generation, brain-penetrant, mutant-selective EGFR tyrosine kinase inhibitor approved for first-line treatment of EGFR-mutated non-small cell lung cancer, including in combination with amivantamab. Post-market safety surveillance is important given its recent approval and evolving real-world use. All FAERS reports with lazertinib as the primary suspect drug were extracted. Proportional Reporting Ratios (PRR), Reporting Odds Ratios (ROR), and chi-squared statistics were calculated for each adverse event. Disproportionality signals were defined by PRR ≥ 2, chi-squared ≥ 3.841, and a minimum of 3 reports. A total of 141 lazertinib reports were identified in the FAERS database. Twenty-six adverse events met all signal detection criteria. The strongest signals were observed for paronychia (PRR 132.90, n = 3), dermatitis acneiform (PRR 118.59, n = 4), peripheral sensory neuropathy (PRR 91.97, n = 3), and peripheral neuropathy (PRR 50.09, n = 28). Dermatologic and neurologic adverse events predominated, consistent with the mechanism of EGFR inhibition. FAERS disproportionality analysis identifies a signal profile for lazertinib dominated by EGFR inhibitor-class dermatologic and neurologic toxicities, alongside an infusion-related reaction signal reflecting combination use with amivantamab. The modest report volume warrants cautious interpretation; however, the signal patterns are mechanistically coherent and consistent with the known toxicity profile of third-generation EGFR TKIs.