Cutaneous adverse events associated with Rybrevant based on FDA Adverse Event Reporting System (FAERS) database from 2021 to 2024

Background Rybrevant (amivantamab), the first bispecific antibody targeting EGFR and MET, has been approved for treating non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Our study employed FAERS database to examine cutaneous adverse events (AEs) associated with rybrevant. Methods Using data from the FAERS between Q2 2021 and Q4 2024, we conducted a comprehensive evaluation of AEs related to rybrevant. Results After data cleaning, 1,372 unique cases were identified where rybrevant was designated as the primary suspect drug. Among these, 483 cutaneous AEs were included for further analysis. At the Preferred Term (PT) level, paronychia, dermatitis acneiform, and skin toxicity showed the highest signal intensities. Sex disparities revealed folliculitis as more prevalent in males. The median time-to-onset (TTO) of cutaneous AEs was 11 days (range: 0–139 days), with rash occurring earliest (median TTO less than 1 days) and skin toxicity latest (median: 139 days). Besides other events, hospitalization events were the most common clinical outcome of cutaneous AEs. Conclusion Rybrevant-associated cutaneous AEs are significant and heterogeneous in real-world settings, with paronychia and dermatitis acneiform representing critical risks. Early monitoring and tailored management are essential, particularly for long-term users.