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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 Immunotherapy for Cutaneous Squamous-cell . . . THE FOOD AND DRUG ADMINISTRATION (FDA) approved the immunotherapy Libtayo (cemiplimab) for high-risk cutaneous squamous-cell carcinoma (CSCC), a common skin cancer type The Oct 8, 2025, approval was based on findings that people given Libtayo after surgery and radiation lived longer without their disease recurring—a measure known as disease-free survival—compared with those treated with
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 adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation
FDA OK’s cemiplimab as adjuvant treatment for skin cancer The FDA has approved cemiplimab-rwlc for adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk for recurrence after surgery and radiation Cemiplimab-rwlc (Libtayo
FDA Approves Cemiplimab-Rwlc for Adjuvant Treatment of . . . The following is a message from the Director of the FDA Oncology Center of Excellence, Dr Richard Pazdur: 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
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)
Dermatology Times 2025 Year in Review: Drug Approvals Libtayo (cemiplimab-rwlc) approved in the US as first and only immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma (CSCC) with a high risk of recurrence after surgery and radiation News release Regeneron Pharmaceuticals October 8, 2025