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 squamous cell carcinoma
FDA Approves Cemiplimab as Adjuvant Treatment for Cutaneous . . . 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
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
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
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
Regeneron’s Libtayo FDA Approved as First Immunotherapy to . . . The FDA has approved a new use of PD-1 inhibitor Libtayo (cemiplimab-rwlc) as a treatment for cutaneous squamous cell carcinoma (CSCC) that has a high risk of recurring after it has been treated with surgery and radiation The approval makes Libtayo the first immunotherapy approved for use after surgery and radiation and may change how patients are treated earlier in their disease As a PD-1
FDA approves Regenerons Libtayo for high-risk CSCC The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals’ fully human monoclonal antibody Libtayo (cemiplimab-rwlc) as an adjuvant therapy for adults with cutaneous squamous cell carcinoma (CSCC) The approval is intended for patients who face an increased risk of the disease returning after surgery and radiation
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 Safety full Prescribing Information