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FDA approves cemiplimab-rwlc for adjuvant treatment of . . . 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
Libtayo (cemiplimab-rwlc) FDA Approval History - Drugs. com 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: cemiplimab-rwlc Dosage form: Injection Company: Sanofi Treatment for: Squamous Cell Carcinoma, Basal Cell Carcinoma, Non Small Cell Lung Cancer Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking
LIBTAYO® (cemiplimab-rwlc) | Official HCP Website 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 Safety full Prescribing Information
FDA Approves Libtayo for Adjuvant Treatment of High-Risk CSCC 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 ® (cemiplimab-rwlc) for the
Libtayo (cemiplimab-rwlc) - OHSU 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 non-squamous cell histology; OR
label - Food and Drug Administration 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)
LIBTAYO® (cemiplimab-rwlc) in Advanced NSCLC, BCC, CSCC . . . 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 including Med Guide