FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous ...
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
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
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 …
FDA Approves Adjuvant Cemiplimab for Cutaneous Squamous Cell …
Oct 8, 2025 · The FDA has approved cemiplimab-rwlc (Libtayo) for the adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery …
Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First and Only ...
Oct 8, 2025 · The FDA approval is based on data from the pivotal Phase 3 C-POST trial investigating adjuvant Libtayo versus placebo in patients with CSCC at high risk of 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 ® …
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.
Cemiplimab-rwlc - NCI - National Cancer Institute
FDA label information for this drug is available at DailyMed. Use in Cancer Cemiplimab-rwlc is approved to treat: Basal cell carcinoma (BCC) (a type of skin cancer).
Libtayo® (cemiplimab) Approved in the European Union as First and …
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. Food and …
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).