Astellas Pharma (JP:4503) has released an update.
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Astellas Pharma Inc. has secured approval from the European Commission for VYLOY (zolbetuximab) in combination with chemotherapy to treat advanced gastric and gastroesophageal junction cancer. Zolbetuximab, the only therapy in the EU targeting the claudin 18.2 biomarker, has demonstrated significant improvements in progression-free and overall survival rates in Phase 3 trials. This approval, extending across the EU and additional states, follows previous approvals in the UK and Japan, with Astellas pursuing further global regulatory submissions.
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