Astellas: FDA Grants Priority Review for Zolbetuximab Biologics License Application

 If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastroesophageal cancers

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in the U.S. for these patients.

https://www.biospace.com/article/releases/astellas-announces-u-s-fda-grants-priority-review-for-zolbetuximab-biologics-license-application/