Adverse events of pexidartinib for the treatment of TGCT: a real-world disproportionality analysis using FDA Adverse Event Reporting System database.

ABSTRACT:

Introduction

Pexidartinib, an oral selective colony-stimulating factor 1 receptor (CSF1R) inhibitor, is the only systemic therapy approved by the U.S. Food and Drug Administration (FDA) for tenosynovial giant cell tumor (TGCT). While clinical trials have defined its initial safety profile, their limited sample sizes and short follow-up restrict the detection of rare or delayed adverse events (AEs), underscoring the need for real-world pharmacovigilance.

Methods

Using the FDA Adverse Event Reporting System (FAERS) database, we conducted a disproportionality analysis to characterize the post-approval safety profile of pexidartinib and identify unlabeled AEs, applying reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network

SUBMITTER: Lin Y 

PROVIDER: S-EPMC12399690 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature