Posted by Michael Wonder on 09 Jun 2023
Astellas submits new drug application for zolbetuximab in Japan
9 June 2023 - Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastro-oesophageal cancers.
Astellas today announced the submission of a New Drug Application on 9 June 2023 to Japan's Ministry of Health, Labour and Welfare 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.
