Post-marketing safety surveillance of Amivantamab: a real world study based on the FDA adverse event reporting system.

Background: Amivantamab stands as the pioneering bispecific antibody that targets both EGFR and MET, utilized in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR ex20ins mutations. Nevertheless, a thorough assessment of its safety characteristics in the real-world remains unknown.

Research design and methods: The adverse event (AE) reports were collected through a search of the FDA Adverse Event Reporting System (FAERS) database spanning from 2019 Q1 to 2024 Q1, and then disproportionality analysis was utilized.

Results: Totally, 9,252,269 AE reports were obtained from the FAERS database, with 893 reports of amivantamab classified as primary suspect AEs. Amivantamab-related AEs were distributed in 23 organ systems, and 87 significant preferred terms (PTs) met the reporting odds ratio criteria. Novel significant AEs were detected, and the median time to onset of amivantamab-associated AEs was 43 days. In subgroup analysis, a higher proportion of patients who were male, over 65 years, and with pneumonitis or pneumonia were reported in the death cases. We also found that AEs may vary between intravenous and subcutaneous administration.

Conclusions: This investigation offered novel prospects for monitoring and addressing undesirable medication effects associated with amivantamab, which might improve the clinical medication safety.