Safety signals of zolbetuximab in gastric or gastroesophageal junction adenocarcinoma: a comprehensive analysis of the FDA adverse event reporting system (FAERS) data - Report - MDSpire
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Safety signals of zolbetuximab in gastric or gastroesophageal junction adenocarcinoma: a comprehensive analysis of the FDA adverse event reporting system (FAERS) data
Clinical Report: Evaluation of Safety Signals for Zolbetuximab in Advanced Gastric Cancer
Overview
This study analyzed 676 adverse event reports related to zolbetuximab from the FAERS database, identifying both known and several unlabeled safety signals.
Background
Zolbetuximab is a monoclonal antibody targeting CLDN18.2, a therapeutic target in advanced gastric or gastroesophageal junction adenocarcinoma. The safety profile of zolbetuximab in real-world settings remains inadequately characterized.
Data Highlights
Adverse Event
Time to Onset
Gastritis
0 days
Protein-losing gastroenteropathy
0 days
Peripheral edema
0 days
Compression fracture
0 days
Vascular pain
0 days
Key Findings
A total of 676 adverse event reports were analyzed from FAERS.
Disproportionality analysis confirmed known gastrointestinal and metabolic disorders.
Several unlabeled adverse events were identified, including gastritis and protein-losing gastroenteropathy.
82.9% of adverse events occurred within the first 30 days of treatment.
The median time-to-onset for reported events was 0 days.
Clinical Implications
Continuous monitoring and reporting of adverse events are essential for patient safety.
Conclusion
This study provides insights into the safety profile of zolbetuximab.
