Zolbetuximab-associated adverse event reporting signals in gastric cancer: a FAERS disproportionality analysis. (PubMed, Front Pharmacol) - Sep 26, 2026 - "We conducted an indication-restricted, report-level US Food and Drug Administration Adverse Event Reporting System (FAERS) analysis from 2024 Q1 through 2026 Q1, comparing 597 zolbetuximab reports with 1,231 pooled nivolumab/pembrolizumab reports. Gastritis and findings related to albumin, protein loss, and fluid balance require clinical confirmation, while protein-losing gastroenteropathy was reported sparsely. Overall, the results characterize reporting disproportionality in an early, Japan-dominant setting, not incidence or comparative clinical risk."
Adverse events • Journal • Gastric Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • PD-1
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Jingshun Zhang; Peng Zhu; Zhijun Li; Zhuo Zhen
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