Safety signals of zolbetuximab in gastric or gastroesophageal junction adenocarcinoma: a comprehensive analysis of the FDA adverse event reporting system (FAERS) data - Takeaways - MDSpire

Safety signals of zolbetuximab in gastric or gastroesophageal junction adenocarcinoma: a comprehensive analysis of the FDA adverse event reporting system (FAERS) data

  • By

  • Li Lin

  • Maohua Chen

  • Chenmin Wu

  • Hong Chen

  • July 10, 2026

  • 0 min

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  • 1

    Zolbetuximab is a monoclonal antibody targeting CLDN18.2 for advanced gastric or gastroesophageal junction adenocarcinoma.

  • 2

    The study analyzed 676 adverse event reports from FAERS to evaluate the safety profile of zolbetuximab.

  • 3

    Disproportionality analysis identified known gastrointestinal disorders and several unlabeled adverse events associated with zolbetuximab.

  • 4

    The median time-to-onset for adverse events was 0 days, with 82.9% occurring within the first 30 days.

  • 5

    This study highlights the need for post-marketing surveillance to uncover potential safety signals for zolbetuximab.

Original Source(s)

Safety signals of zolbetuximab in gastric or gastroesophageal junction adenocarcinoma: a comprehensive analysis of the FDA adverse event reporting system (FAERS) data

  • by Li Lin, Maohua Chen, Chenmin Wu, Hong Chen

  • July 10, 2026

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