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相关临床试验
48
48 进行中
药物批准
3
批准总数
监管机构
2
监管机构数
成立时间
2000
进行中（未招募）
100.0%
NMPA
National Medical Products Administration
1
FDA
Food and Drug Administration
- Japan's Ministry of Health, Labour and Welfare approved Zynyz (retifanlimab) in combination with carboplatin and paclitaxel as the first and only first-line treatment for advanced squamous cell carcinoma of the anal canal. - The approval was based on Phase 3 POD1UM-303/InterAACT2 trial data showing a statistically significant 37% reduction in risk of progression or death compared to placebo combination. - Patients receiving Zynyz combination therapy achieved a median progression-free survival of 9.3 months versus 7.4 months for placebo combination group. - This marks the first regulatory approval for Zynyz in Japan and the second global approval for this indication following FDA approval in May 2025.
