Astellas’ Vyloy (Zolbetuximab) Receives EU Approval for Advanced Gastric and Gastroesophageal Junction Cancer Treatment

EU Approval:
The European Commission has approved Astellas' Vyloy (zolbetuximab) in combination with chemotherapy for the treatment of advanced gastric and gastroesophageal junction cancer.

First-in-Class Therapy:
Zolbetuximab is the first and only therapy approved in the European Union to target claudin 18.2, a biomarker positively expressed by 38% of patients with advanced gastric cancer.

Clinical Trials:
The approval is based on data from the Phase 3 SPOTLIGHT and GLOW clinical trials, which showed statistically significant improvements in progression-free survival (PFS) with zolbetuximab plus chemotherapy compared to placebo plus chemotherapy.

Precision Medicine:
Zolbetuximab represents a new era in precision medicine for these advanced cancers, underlining Astellas' commitment to pioneering scientific discovery to advance patient outcomes.

Global Regulatory Status:
Zolbetuximab has also been approved in Japan and is undergoing regulatory review in the USA, China, Australia, and several other countries.