Japan Approves Incyte’s Zynyz as First-Line Treatment for Advanced Anal Cancer

Reuters2025-12-22
Japan Approves Incyte’s Zynyz as First-Line Treatment for Advanced Anal Cancer

Incyte Biosciences Japan has received approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel as a first-line treatment for advanced squamous cell carcinoma of the anal canal (SCAC). This marks the first regulatory approval for Zynyz in Japan and follows its earlier approval by the U.S. FDA for the same indication. The approval is based on Phase 3 trial data demonstrating a significant reduction in the risk of disease progression or death compared to chemotherapy alone. Incyte has also submitted a marketing authorization application for retifanlimab to the European Medicines Agency.

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