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 …
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.
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 …
Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First ... - BioSpace
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 …
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).
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 - FDA Drug Approval Details - trial.medpath.com
Detailed FDA approval information for LIBTAYO, including regulatory status, product details, and official drug labeling information.