EMA accepts Astellas' zolbetuximab MAA

The European Medicines Agency (EMA) has accepted for regulatory review Astellas Pharma’s (TYO: 4503) marketing authorization application (MAA) for zolbetuximab.

The Japanese drugmaker’s Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody is under development 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.

"Innovative therapies that extend survival are needed"If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Europe for these patients.