Evaluation of the safety profile of amivantamab based on real-world evidence: a call to vigilance

Amivantamab has been approved for EGFR exon 20 insertion-mutated non-small-cell lung cancer. The aim of this study was to perform an in-depth analysis of its safety profile. Safety reports were collected from the database of the Food and Drug Administration Adverse Event Reporting System from April 2021 to September 2023, and the reporting odds ratio (ROR) method was used to detect potential safety signals. Mobocertinib, an agent with similar properties to amivantamab, served as a control for comparison. A total of 88 safety signals were detected, most of which were novel. In comparison with mobocertinib, amivantamab appeared to cause more injury, poisoning, and procedural complications (ROR = 15.54, 95% CI 10.25–23.58); respiratory, thoracic, and mediastinal disorders (ROR = 1.92, 95% CI 1.57–2.34); infections and infestations (ROR = 1.39, 95% CI 1.09–1.76); blood and lymphatic system disorders (ROR = 9.57, 95% CI 6.17–14.84); and immune system disorders (ROR = 6.41, 95% CI 3.14–13.12). Moreover, amivantamab was associated with higher risks of thrombosis events, bone marrow suppression, skin and soft tissue infection, deterioration of respiratory symptoms, and noninfectious pneumonitis. The safety profile of amivantamab requires attention; particularly, monitoring of the adverse drug events described above is necessary during its administration.