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 …
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 …
Covering Every FDA Oncology Approval From October 2025
4 days ago · FDA Approves Libtayo for High-Risk Cutaneous Squamous Cell Carcinoma The FDA has approved Libtayo (cemiplimab-rwlc) for adjuvant treatment in adults with cutaneous …
Libtayo (cemiplimab-rwlc) FDA Approval History - Drugs.com
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 …
Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First and …
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 …
Cemiplimab Gains FDA Approval for Adjuvant High-Risk CSCC
Oct 11, 2025 · The FDA has approved adjuvant cemiplimab (Libtayo) for adults with high-risk cutaneous squamous-cell carcinoma after surgery and radiation.
FDA OK’s cemiplimab as adjuvant treatment for skin cancer
Oct 9, 2025 · The FDA has approved cemiplimab-rwlc for adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk for recurrence after surgery and …
FDA Approves Libtayo for Adjuvant Treatment of High-Risk CSCC
Oct 9, 2025 · 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 …
FDA approves Libtayo for high-risk CSCC after surgery and …
Oct 8, 2025 · TARRYTOWN, N.Y. - The U.S. Food and Drug Administration has approved Regeneron Pharmaceuticals’ (NASDAQ:REGN) Libtayo (cemiplimab-rwlc) as an adjuvant …
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).