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

Oct 8, 2025 · The FDA evaluated Libtayo under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of serious …

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 cisplatin for …

Oct 9, 2025 · The U.S. Food and Drug Administration approved adjuvant cemiplimab (Libtayo) for adults with cutaneous squamous cell carcinoma who are at a high risk for recurrence after surgery and …

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

Permanently discontinue LIBTAYO for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive …

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).

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Immune-Mediated Adverse Reactions Advise patients that LIBTAYO can cause immune-mediated adverse reactions …

FDA approves Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative …

The recommended cemiplimab-rwlc dose and schedule is 350 mg as an intravenous infusion over 30 minutes every 3 weeks. View full prescribing information for LIBTAYO.