ORIGINAL RESEARCH article
Front. Oncol.
Sec. Pharmacology of Anti-Cancer Drugs
Volume 15 - 2025 | doi: 10.3389/fonc.2025.1594585
This article is part of the Research TopicOptimizing Cancer Treatment Timing: Balancing Patient Outcomes and Healthcare EfficiencyView all articles
Adverse events of pexidartinib for the treatment of TGCT: A real-world disproportionality analysis using FDA Adverse Event Reporting System database
Provisionally accepted
- 1Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China
- 2Pingtan Comprehensive Experimental Area Hospital, Fuzhou, China
- 3Fujian Provincial Hospital, Fuzhou, Fujian Province, China
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Pexidartinib, an oral selective inhibitor of colony-stimulating factor 1 receptor (CSF1R), is the only systemic therapy approved by the Food and Drug Administration (FDA) for tenosynovial giant cell tumor (TGCT), warranting ongoing post-marketing safety monitoring.While clinical trials established initial safety profiles, their limited sample sizes and short-term follow-up underscore the need for real-world pharmacovigilance. Utilizing the FDA Adverse Event Reporting System (FAERS) database, we conducted a comprehensive disproportionality analysis to characterize pexidartinib's post-approval safety profile and identify unanticipated adverse events (AEs). We assessed the disproportionality of pexidartinib-related AEs by calculating measures including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and multi-item gamma Poisson shrinker (MGPS). Among 7,168,342 reports, 668 implicated pexidartinib as the primary suspected drug, uncovering AEs across 26 organ systems. This analysis revealed 67 significant preferred terms (PTs) satisfying all four methodologies. Notably, 16 newly identified AEs unmentioned in the FDA label of pexidartinib were identified. Our findings align with previous clinical trials, highlighting potential unexpected AEs associated with pexidartinib. These findings emphasize the importance of ongoing post-marketing surveillance for targeted therapies and highlight the need for prospective studies to establish causal relationships between pexidartinib and the newly identified AEs.This study demonstrates the utility of pharmacovigilance databases in complementing clinical trial data for comprehensive drug safety assessment.
Keywords: Pingtan Comprehensive Experimental Area Hospital, No. 2, Linhu 7th Road ) Disproportionality analysis, FAERS database, Pexidartinib, Real-world adverse events, Tenosynovial giant cell tumor Disproportionality analysis, Tenosynovial giant cell tumor
Received: 16 Mar 2025; Accepted: 28 Jul 2025.
Copyright: © 2025 Lin, Zheng, Lin and Chen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Maohua Chen, Pingtan Comprehensive Experimental Area Hospital, Fuzhou, China
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