CHMP Issues Positive Opinion for Astellas' Zolbetuximab in Combination with Chemotherapy for Treatment of Advanced Gastric and Gastroesophageal Junction Cancer
Astellas Pharma Inc.announced that on July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of zolbetuximab in the European Union. Zolbetuximab, a first-in-class claudin (CLDN) 18.2-targeted monoclonal antibody, is recommended in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive
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If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2-targeted therapy approved in the European Union
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A decision on the EU marketing authorization is expected by October 2024
The positive CHMP opinion is based on the results from the Phase 3 SPOTLIGHT and GLOW clinical trials which explored the efficacy and safety of first-line zolbetuximab treatment in adult patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive.