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 …
FDA Approves Adjuvant Cemiplimab for Cutaneous Squamous …
Oct 8, 2025 · The FDA approved cemiplimab-rwlc for the adjuvant treatment of cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.
Behind the FDA Approval: Adjuvant Cemiplimab Shifts Treatment …
Oct 22, 2025 · Vishal A. Patel, MD, discusses the FDA approval of cemiplimab in cutaneous squamous cell carcinoma. On October 8, 2025, the US FDA approved the immunotherapy …
FDA Approves Cemiplimab as Adjuvant Treatment for …
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 …
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 …
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 as First Adjuvant Immunotherapy for High …
Oct 9, 2025 · The FDA has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as the first and only immunotherapy for the adjuvant treatment of cutaneous squamous cell carcinoma …
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 …
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 …
REGN Gets EC Nod for Libtayo Label Expansion, FDA Clears …
Nov 20, 2025 · Regeneron gains EC approval to expand Libtayo's use in high-risk CSCC. The FDA approves Eylea HD the treatment of patients with macular edema following retinal vein …