8 January 2024 - Astellas Pharma today announced the US FDA issued a complete response letter on 4 January 2024, regarding the biologics license application for zolbetuximab, an investigational agent for the treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 negative gastric or gastro-oesophageal junction adenocarcinoma whose tumours are claudin 18.2 positive.

The FDA stated that the agency cannot approve the biologics license application by the PDUFA action date of 12 January 2024, due to unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab.

Read Astellas press release