FDA acknowledges BLA resubmission for Zolbetuximab for HER2- gastric or GEJ adenocarcinoma with CLDN18.2-positive tumors

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Astellas Pharma Inc. announced that FDA has acknowledged the company’s resubmission of the Biologics License Application for zolbetuximab, a first-in-class investigational claudin 18.2-targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive. 

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