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Astellas' Marketing Authorisation Application for Zolbetuximab Accepted by the European Medicines Agency

Friday, July 14, 2023

Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for zolbetuximab.

Zolbetuximab is a novel monoclonal antibody that targets Claudin 18.2 (CLDN18.2), and it is being investigated as a first-line therapy for patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumours are CLDN18.2-positive.

If approved, zolbetuximab would be the first treatment option in Europe specifically designed to target CLDN18.2 for these patients. The MAA is based on the results from two Phase 3 clinical trials: the SPOTLIGHT study and the GLOW study.

The MAA submission was supported by data from two Phase 3 clinical trials: the SPOTLIGHT study and the GLOW study. In the SPOTLIGHT study, zolbetuximab was evaluated in combination with mFOLFOX6, while the GLOW study assessed its combination with CAPOX. Both combinations were compared to a placebo plus the respective chemotherapy regimen.

Gastric cancer patients in Europe face challenges, and survival rates remain low across all stages of the disease. As such, there is a critical need for innovative therapies that can improve patient outcomes and extend survival. The acceptance of the zolbetuximab MAA by the EMA represents a significant regulatory milestone and brings hope for a new treatment option in this setting.

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