Pharmaceutical company Astellas Pharma Inc. (TSE:4503) announced on Friday that the US FDA has approved VYLOY (zolbetuximab-clzb) in combination with chemotherapy for first-line treatment of adults with CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma.

VYLOY is the first CLDN18.2-targeted therapy approved in the US, based on Phase 3 SPOTLIGHT and GLOW trials that demonstrated improved progression-free and overall survival compared to chemotherapy alone.

Astellas collaborated with Roche to develop the VENTANA CLDN18 (43-14A) RxDx Assay, an FDA-approved diagnostic test to identify eligible patients. VYLOY is now approved in five global markets, including Japan, the UK, the EU, South Korea and the US Additional regulatory reviews are ongoing worldwide.