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  1. 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 …

  2. 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

  3. 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 …

  4. FDA Approves Adjuvant Cemiplimab for Cutaneous Squamous …

    Oct 8, 2025 · The FDA has approved cemiplimab-rwlc (Libtayo) for the adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after …

  5. Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First and …

    Oct 8, 2025 · The FDA approval is based on data from the pivotal Phase 3 C-POST trial investigating adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence …

  6. 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 …

  7. Cemiplimab Gains FDA Approval for Adjuvant High-Risk CSCC

    Oct 11, 2025 · The FDA has approved adjuvant cemiplimab (Libtayo) for adults with high-risk cutaneous squamous-cell carcinoma after surgery and radiation.

  8. FDA Approval of Cemiplimab: A New Era for High-Risk CSCC …

    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 …

  9. LIBTAYO® (cemiplimab-rwlc) in Advanced NSCLC, BCC, CSCC

    Learn about LIBTAYO® (cemiplimab-rwlc) in the treatment of advanced NSCLC, BCC, CSCC, & as an adjuvant treatment for high-risk CSCC. Review Important Safety Info & Full Prescribing …

  10. During the treatment period ranging from 8 to 19 months in 5 clinical studies, the incidence of anti-cemiplimab-rwlc antibodies in LIBTAYO-treated patients was 2% (22/1029).