Posted by Michael Wonder on 19 Nov 2025
Libtayo (cemiplimab) approved in the European Union as first and only immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma with high risk of recurrence after surgery and radiation
19 November 2025 - Approval based on results of landmark Phase 3 C-POST trial that show Libtayo is first immunotherapy to significantly improve disease-free survival in cutaneous squamous cell carcinoma in the adjuvant setting, reducing the risk of recurrence or death by 68% (hazard ratio = 0.32; 95%CI: 0.20-0.51; p<0.0001).
Regeneron Pharmaceuticals today announced that the European Commission has approved the PD-1 inhibitor Libtayo (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.
