Neurological adverse events of ROS1 inhibitors for non-small cell lung cancer: data from the FDA adverse event reporting system.

ABSTRACT:

Background

ROS1 inhibitors play a critical role in the treatment of ROS1 fusion-positive non-small cell lung cancer (NSCLC). Although agents such as Crizotinib, Ceritinib, Lorlatinib, Entrectinib, and Repotrectinib have demonstrated strong efficacy and intracranial activity, their neurological safety profiles remain insufficiently characterized in real-world settings. This study aimed to evaluate the neurological adverse events (AEs) of ROS1 inhibitors using the FDA Adverse Event Reporting System (FAERS) database.

Methods

We conducted a pharmacovigilance analysis of FAERS reports from 2011Q4 to 2024Q4. Disproportionality analysis was used to detect potential AE signals, followed by time-to-onset and logistic regression analyses to assess the onset timing and mortality risk a

SUBMITTER: Wei X 

PROVIDER: S-EPMC12823534 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature