Astellas Pharma Inc. announced that the U.S. Food and Drug Administration has accepted and granted Priority Review for the company’s Biologics License 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 gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive.
July 6, 2023
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