FDA Acknowledges Astellas Pharma's Resubmission Of BLA For Zolbetuximab

(RTTNews) - The U.S. Food and Drug Administration has acknowledged Astellas Pharma'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, the company said in a statement.

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.

The zolbetuximab BLA was resubmitted on May 9, 2024, following a complete response letter issued on January 4, 2024 by the FDA due to third-party manufacturing deficiencies identified during the pre-license inspection of the facility. The FDA did not raise any concerns related to the clinical data, including efficacy or safety, of zolbetuximab, and did not request additional clinical studies to support the BLA approval.

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