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
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 Cemiplimab as First, Only Adjuvant Immunotherapy …
Oct 8, 2025 · Cemiplimab is the first immunotherapy approved for adjuvant treatment in CSCC, offering a new option for patients at high risk of recurrence.
FDA Approves Cemiplimab for Adjuvant Cutaneous Squamous Cell …
Oct 8, 2025 · The US FDA has approved the supplemental biologics license application (sBLA) for cemiplimab-rwlc (Libtayo) as adjuvant treatment in adults with high-risk cutaneous squamous cell …
Other treatment options including, but are not limited to, the following may be appropriate: radiation therapy, surgery, traditional chemotherapy (e.g., platinum, taxane), compassionate use/expanded …
FDA Approves Cemiplimab as Adjuvant Immunotherapy for High …
Oct 13, 2025 · Key Takeaways Cemiplimab-rwlc (Libtayo) is the first FDA-approved immunotherapy for high-risk CSCC post-surgery and radiation, reducing recurrence risk by 68%. The phase 3 C-POST …
FDA Approves Cemiplimab as Adjuvant Treatment for Cutaneous …
Oct 8, 2025 · Cemiplimab's approval is supported by findings from the C-POST clinical trial. The FDA approved cemiplimab-rwlc (Libtayo; Regeneron Pharmaceuticals) for the adjuvant treatment of adults …
Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First and Only ...
Oct 8, 2025 · Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First and Only Immunotherapy for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) with a High Risk of …
FDA Approval of Cemiplimab: A New Era for High-Risk CSCC Treatment
Oct 28, 2025 · In a significant step forward for skin cancer management, the U.S. Food and Drug Administration (FDA) has approved cemiplimab-rwlc (Libtayo) as an adjuvant treatment for adults …