BRIEF—FDA acknowledges Astellas’ BLA resubmission for zolbetuximab

Today, Japanese pharma major Astellas announced the US Food and Drug Administration (FDA) has acknowledged the company’s resubmission of the Biologics License Application (BLA) for zolbetuximab, 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 claudin (CLDN) 18.2 positive.

Under the Prescription Drug User Fee Act, the FDA has set a new target action date of November 9, 2024.

If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in the U.S. for these patients.

The BLA was resubmitted following a complete response letter issued by the FDA on January 4, 2024, 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.