Astellas Pharma Inc. announced the U.S. Food and Drug Administration issued a complete response letter on January 4, 2024, regarding the Biologics License Application for zolbetuximab, an investigational agent for the treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 -negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 positive.
January 8, 2024
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