Astellas gets first approval for Vyloy, in Japan

26 March 2024

Japanese drug major Astellas Pharma (TYO: 4503) today announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Vyloy (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer.

Astellas noted that this makes Vyloy is the first and only CLDN18.2-targeted therapy approved by any regulatory agency in the world. The company’s shares edged up 1.3% to 1,674 yen on the news.

Gastric cancer is frequently diagnosed in the advanced or metastatic stage due to overlapping early-stage symptoms with other more common stomach conditions. Despite efforts to reduce its impact, gastric cancer is the third deadliest cancer in Japan, with 126,724 cases diagnosed in 2022.

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