Post-marketing safety concerns of sotorasib: A disproportionality analysis based on FDA adverse event reporting system

• DOI: 10.1016/j.heliyon.2024.e30437
• Publication Date: 2024-04-27T01:25:41Z
• Authors: Yiling Ding; Hongyan Su; Yamin Shu; Jing Chen
• Keywords: Interquartile range; Quartile; Marketing authorization

BackgroundSotorasib has been approved for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Due to limitations clinical trials, potential adverse events (AEs) and long-term safety issues cannot be detected. The presented study aimed evaluate sotorasib-associated AEs using FDA Adverse Event Reporting System (FAERS) database.MethodsPost-marketing AE reports sotorasib in database were collected analysis. Disproportionality analyses, including reporting odds ratio (ROR), proportional (PRR), information component (IC) empirical bayes geometric mean (EBGM) algorithms, performed mine signals AEs. median duration, quartiles Weibull shape parameter (WSP) test used assess onset time data.ResultsThe contained 1538 cases as primary suspected (PS), 27 detected, scattering 5 SOCs. SOC hepatobiliary disorders (182, ROR 4.48, PRR 4.07, IC 2.02, EBGM 4.07) met four methodological thresholds. was 42 days (interquartile range [IQR] 14-86.75 days). Different SOCs had different types risk over time.ConclusionAfter obtaining marketing authorization, identified all potentially relevant event (AE) expected have a frequency higher than anticipated characterized them during treatment.