On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous …

Oct 9, 2025 · FDA approval history for Libtayo (cemiplimab-rwlc) used to treat Squamous Cell Carcinoma, Basal Cell Carcinoma, Non Small Cell Lung Cancer. Supplied by Sanofi

LIBTAYO® (cemiplimab-rwlc) is a prescription medicine indicated for the treatment of adult patients with advanced NSCLC, CSCC, BCC, and as an adjuvant treatment for high-risk …

Oct 8, 2025 · The FDA approval is based on data from the pivotal Phase 3 C-POST trial investigating adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence …

Oct 8, 2025 · The FDA has approved cemiplimab-rwlc (Libtayo) for the adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after …

Oct 11, 2025 · The FDA has approved adjuvant cemiplimab (Libtayo) for adults with high-risk cutaneous squamous-cell carcinoma after surgery and radiation.

During the treatment period ranging from 8 to 19 months in 5 clinical studies, the incidence of anti-cemiplimab-rwlc antibodies in LIBTAYO-treated patients was 2% (22/1029).

Used as continuation maintenance therapy in patients who have achieved a tumor response or stable disease after first-line therapy with cemiplimab, pemetrexed, and either carboplatin or …

Oct 9, 2025 · Findings showed cemiplimab reduced the risk of disease recurrence or death by 68% compared with placebo. The Food and Drug Administration (FDA) has approved Libtayo …

Learn about LIBTAYO® (cemiplimab-rwlc) in the treatment of advanced NSCLC, BCC, CSCC, & as an adjuvant treatment for high-risk CSCC. Review Important Safety Info & Full Prescribing …