The US FDA has approved the supplemental biologics license application (sBLA) for cemiplimab-rwlc (Libtayo) as adjuvant treatment in adults with high-risk cutaneous squamous cell carcinoma (CSCC).1
The sBLA approval was based on an extensive review of data from the pivotal phase 3 C-POST study (NCT03969004) which demonstrated a statistically significant and clinically meaningful improvement in its primary end point of disease-free survival (DFS) since interim analysis data were initially shared in January 2025.1,2 The updated findings, including additional data for DFS and positive secondary end point data, reinforce this forable trend and were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine.3–6
For the primary end point, cemiplimab was associated with a 68% reduction (HR, 0.32; 95% CI, 0.20–0.51; P