TOKYO (dpa-AFX) - Astellas Pharma Inc. (ALPMY) announced on Tuesday that
Japan's Ministry of Health, Labour and Welfare has approved Vyloy or
zolbetuximab, an anti-claudin 18.2 also known as CLDN18.2 monoclonal antibody
for patients with gastric cancer.

Vyloy is the first CLDN18.2-targeted therapy approved by any regulatory agency
globally.

The approval is based on findings from the Phase 3 SPOTLIGHT and GLOW clinical
trials for first-line treatment in patients whose tumors tested positive for
CLDN18.2.

Astellas has also filed applications for Vyloy with regulatory agencies
worldwide, and the review process is currently underway.



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