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
Libtayo® (cemiplimab-rwlc) Approved in the U. S. as First and . . . 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 Recurrence After Surgery and Radiation
FDA Approves Libtayo for Adjuvant Treatment of High-Risk CSCC The Food and Drug Administration (FDA) has approved Libtayo ® (cemiplimab-rwlc) for the adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of
FDA Approves Cemiplimab as Adjuvant Immunotherapy for High . . . 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 trial showed cemiplimab significantly improved 24-month disease-free survival compared to placebo Cemiplimab's safety profile aligns with its use in other skin cancers, with common adverse events including rash and
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
label - accessdata. fda. gov 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
Regeneron Receives FDA Approval for Libtayo; 68% Risk . . . Regeneron (NASDAQ: REGN) announced FDA approval of Libtayo (cemiplimab-rwlc) as the first and only immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation, approved Oct 8, 2025 Approval was based on Phase 3 C-POST results showing a 68% reduction in risk of disease recurrence or death versus placebo (HR 0 32; 95%