Astellas Pharma US, Inc. recently announced that the European Medicines Agency has accepted the Marketing Authorization Application (MAA) for regulatory review of zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for the potential 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.
If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Europe for eligible patients. The MAA is based on positive results from the phase 3 SPOTLIGHT and GLOW trials, which are part of Astellas’ gastric cancer development program to investigate targeted treatment options and address patient needs.
In this interview, GI Oncology Now spoke with Pranob Bhattacharya, executive director and global development project leader, oncology, Astellas Pharma Global Development, about the dangers of gastric cancer and how zolbetuximab may effectively treat the malignancy.