EMA Accepts Astellas' Marketing Authorization Application For Zolbetuximab

(RTTNews) - Astellas Pharma Inc. said that the European Medicines Agency (EMA) has accepted for regulatory review the company's marketing authorization 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 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 these patients.

The anticipated recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the EMA regarding the MAA and subsequent European Commission decision are expected in calendar year 2024.

Astellas noted that it has already reflected the impact from the acceptance in its financial forecast of the current fiscal year ending March 31, 2024.

For More Such Health News, visit rttnews.com