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 9, 2025 · Libtayo FDA Approval History Last updated by Judith Stewart, BPharm on Oct 9, 2025. FDA Approved: Yes (First approved September 28, 2018) Brand name: Libtayo Generic name: …

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 …

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. See Important …

LIBTAYO (cemiplimab-rwlc) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH of 6.

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 cisplatin for …

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 Information …

Oct 9, 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 …

Nov 19, 2025 · 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. …