{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T05:13:47Z","timestamp":1783660427331,"version":"3.55.0"},"reference-count":36,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T00:00:00Z","timestamp":1783641600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Oncol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Zolbetuximab is a novel monoclonal antibody targeting CLDN18.2 for advanced gastric or gastroesophageal junction adenocarcinoma. However, its large-scale, real-world safety profile remains incompletely characterized. This study aimed to analyze its post-marketing adverse events using the FDA Adverse Event Reporting System (FAERS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adverse event reports from FAERS (Q1 2024 \u2013 Q3 2025) with zolbetuximab as the primary suspect were analyzed. Disproportionality analysis using four algorithms (ROR, PRR, IC, and EBGM) was performed to detect potential safety signals. Time-to-onset analysis was also conducted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 676 reports were analyzed. Disproportionality analysis confirmed known gastrointestinal and metabolic disorders while identifying several unlabeled adverse events, including but not limited to gastritis, protein-losing gastroenteropathy, peripheral edema, compression fracture, and vascular pain. The median time-to-onset was 0 days, with 82.9% of events occurring within the first 30 days.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This first large-scale pharmacovigilance study of zolbetuximab detected several potential safety signals not currently listed in the prescribing information. These findings highlight the importance of post-marketing surveillance and should be interpreted as hypothesis-generating, warranting further validation in clinical and real-world studies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fonc.2026.1787423","type":"journal-article","created":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T04:25:29Z","timestamp":1783657529000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety signals of zolbetuximab in gastric or gastroesophageal junction adenocarcinoma: a comprehensive analysis of the FDA adverse event reporting system (FAERS) data"],"prefix":"10.3389","volume":"16","author":[{"given":"Li","family":"Lin","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial Hospital","place":["Fuzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maohua","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital","place":["Fuzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chenmin","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Immunology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial Hospital","place":["Fuzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Neurology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital","place":["Fuzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,7,10]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1177\/17588359251363057","article-title":"Systemic therapy strategies for elderly patients with gastric cancer","volume":"17","author":"Narita","year":"2025","journal-title":"Ther Adv Med Oncol"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.46883\/2024.25921031","article-title":"Efficacy and safety of zolbetuximab in gastric cancer","volume":"38","author":"Waheed","year":"2024","journal-title":"Oncol (Williston Park NY)"},{"key":"B3","doi-asserted-by":"publisher","first-page":"5742","DOI":"10.3390\/cancers15245742","article-title":"Claudin18.2 in advanced gastric cancer","volume":"15","author":"Inamoto","year":"2023","journal-title":"Cancers"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinre.2023.102245","article-title":"New developments and standard of care in the 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