Posted by Michael Wonder on 06 Jul 2023
Astellas announces US FDA grants priority review for zolbetuximab biologics license application
6 July 2023 - Astellas Pharma today announced that the US FDA has accepted and granted priority review for the company’s iologics license application for zolbetuximab, a first in class investigational Claudin 18.2 (CLDN18.2) targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction adenocarcinoma whose tumours are CLDN18.2 positive.
If approved, zolbetuximab would be the first CLDN18.2 targeted therapy available in the US for these patients.
