13 July 2023 - Astellas Pharma today announced the EMA has accepted for regulatory review the company's marketing authorisation application for zolbetuximab, a first in class investigational Claudin 18.2 targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction adenocarcinoma whose tumours are CLDN18.2 positive. 

If approved, zolbetuximab would be the first CLDN18.2 targeted therapy available in Europe for these patients.

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