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

2025年10月9日 · FDA approval history for Libtayo (cemiplimab-rwlc) used to treat Squamous Cell Carcinoma, Basal Cell Carcinoma, Non Small Cell Lung Cancer. Supplied by Sanofi

2025年10月8日 · The FDA evaluated Libtayo under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the …

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 CSCC. …

2025年10月11日 · The FDA has approved adjuvant cemiplimab (Libtayo) for adults with high-risk cutaneous squamous-cell carcinoma after surgery and radiation.

2025年10月8日 · The FDA evaluated Libtayo under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the …

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).

FDA label information for this drug is available at DailyMed. Use in Cancer Cemiplimab-rwlc is approved to treat: Basal cell carcinoma (BCC) (a type of skin cancer).

This expands the existing European Union (EU) indication for Libtayo in advanced CSCC to include patients at high risk of disease recurrence. Libtayo was also recently approved by the U.S. Food …

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 …