A decision on the FDA approval for Astellas Pharma’s zolbetuximabto is anticipated on 12 January 2024. Credit: Raysonho @ Open Grid Scheduler / Grid Engine / commons.wikimedia.org.

The US Food and Drug Administration (FDA) has awarded priority review for Astellas Pharma’s biologics licence application (BLA) for zolbetuximab to treat gastric cancer patients.

Zolbetuximab is an investigational monoclonal antibody that acts on Claudin 18.2 (CLDN18.2). It is intended for use as a first-line therapy for HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma that is locally advanced, unresectable or metastatic, with tumours that are CLDN18.2-positive.

Zolbetuximab is the first treatment targeting CLDN18.2 to be offered in the region for such patients.

A decision on the approval by the regulatory agency is anticipated on 12 January 2024.

The application is based on the Phase III SPOTLIGHT and GLOW clinical trial findings.

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The GLOW trial analysed zolbetuximab in combination with a chemotherapy regimen comprising capecitabine and oxaliplatin (CAPOX).

Astellas immuno-oncology development senior vice-president and head Moitreyee Chatterjee-Kishore stated: “Astellas is committed to bringing innovative therapies to patients with hard-to-treat cancers, including gastric cancer.

“The FDA’s acceptance of the biologics licence application filing and priority review designation for zolbetuximab confirms the urgent therapeutic need and brings us one step closer to delivering on this commitment to patients, families and caregivers.”

In June 2023, the company filed a new drug application with the Japanese Ministry of Health, Labour and Welfare for zolbetuximab to treat advanced gastric and gastroesophageal cancer.