Anastelica (ALPN-18.2) monoclonal antibody received a positive opinion for marketing authorisation in the EU

AstraZeneca (Astellas Pharma, ALPMY.US) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of zolbetuximab for use in the European Union in combination with fluorouracil or platinum-based chemotherapy as first-line treatment for adult patients with locally advanced or metastatic HER2-negative gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ) if CLDN18.2 is positive. If approved, zolbetuximab will be the first marketed CLDN18.2-targeting therapy in the European Union.

Zolbetuximab is a first-in-class monoclonal antibody targeting CLDN18.2 and was approved in Japan in March 2024, becoming the first CLDN18.2-targeting therapy to be approved by a regulatory agency globally.