Japanese pharmaceutical company Astellas Pharma has submitted a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare for zolbetuximab, an investigational Claudin 18.2-targeted monoclonal antibody being evaluated as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive. If approved, it would be the first CLDN18.2-targeted therapy available in Japan for these patients. Gastric cancer kills 50,000 people per year in Japan and remains the third deadliest cancer in the country despite efforts to reduce its impact. The NDA is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials.
Keywords: Astellas Pharma, zolbetuximab, New Drug Application (NDA), Japan's Ministry of Health, Labour and Welfare, gastric cancer
Additional sentence: Zolbetuximab is an investigational chimeric IgG1 monoclonal antibody that targets and binds to CLDN18.2, a transmembrane protein that induces cancer cell death by activating two distinct immune system pathways - antibody-dependent cellular cytotoxic