30 May 2024 - If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastro-oesophageal junction cancers as the first and only CLDN18.2 targeted therapy in the US.

Astellas Pharma today announced that the US FDA has acknowledged the company's resubmission of the biologics license application for zolbetuximab, a first in class investigational claudin 18.2 targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 negative gastric or gastro-oesophageal junction adenocarcinoma whose tumours are CLDN18.2 positive.

Read Astellas press release