FDA New Action Date on Astellas Application for Zolbetuximab

 If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastroesophageal junction cancers as the first and only CLDN18.2-targeted therapy in the U.S.

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the company's resubmission of the Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational claudin (CLDN) 18.2-targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (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 approved for this patient population in the U.S. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a new target action date of November 9, 2024.

https://www.biospace.com/article/releases/u-s-fda-acknowledges-astellas-resubmission-of-biologics-license-application-for-zolbetuximab-and-sets-new-action-date/