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  • FDA Approves Cemiplimab as Adjuvant Treatment for Cutaneous . . .
    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 with cutaneous squamous cell carcinoma (CSCC) who are at a high risk of recurrence following surgery and radiation
  • Behind the FDA Approval: Adjuvant Cemiplimab Shifts Treatment . . .
    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 cemiplimab-rwlc (Libtayo) for adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence
  • Libtayo® (cemiplimab-rwlc) Approved in the U. S. as First
    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 conditions
  • FDA Approves Libtayo for Immunotherapy for Adjuvant Treatment . . .
    FDA approved of Regeneron Pharmaceutical’s Libtayo (cemiplimab-rwlc)as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) who are at an increased risk of recurrence following surgery and radiation 1 Libtayo was reviewed by FDA under Priority Review, a method reserved for medicines representing a potential improvement in efficacy or safety in treatments of
  • FDA Approves Cemiplimab as Adjuvant Immunotherapy for High . . .
    Last week, Regeneron announced the U S Food and Drug Administration (FDA) approval of cemiplimab-rwlc (Libtayo) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC), particularly in those with a high risk of recurrence after surgery and radiation 1 The PD-1 inhibitor was evaluated under priority review
  • REGN Gets EC Nod for Libtayo Label Expansion, FDA Clears . . .
    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 occlusion
  • FDA Approves Libtayo to Help Prevent Return of High-Risk Skin . . .
    The FDA has approved cemiplimab-rwlc (Libtayo) as a new treatment option to help prevent cutaneous squamous cell carcinoma (CSCC) from returning after surgery and radiation This approval brings hope to adults with CSCC who are at high risk of the cancer coming back, offering another way to lower the chances of recurrence Who Can Benefit? This new approval is intended for patients who have
  • FDA Approves Libtayo for Adjuvant Treatment of High-Risk CSCC
    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-rwlc) for the


















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