Real-world pharmacovigilance analysis unveils the toxicity profile of amivantamab targeting EGFR exon 20 insertion mutations in non-small cell lung cancer.

ABSTRACT:

Background

While clinical trials have demonstrated enduring responses to amivantamab among advanced non-small cell lung cancer (NSCLC) patients bearing EGFR exon 20 insertion mutations, the associated toxicity profile in real-world scenarios remains elusive.

Methods

This pharmacovigilance study analyzed data from the FDA Adverse Event Reporting System (FAERS) to investigate adverse events associated with amivantamab over the period from September 2021 to December 2023. A comprehensive disproportionality analysis was performed, employing the reporting odds ratio (ROR), proportional reporting ratio (PRR), Empirical Bayes Geometric Mean (EBGM), and the Bayesian confidence propagation neural network to calculate information components (ICs), to identify statistically significant

SUBMITTER: Zhang J 

PROVIDER: S-EPMC11800505 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature