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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. FDA Approves Cemiplimab as First, Only Adjuvant …

    Oct 8, 2025 · Cemiplimab is the first immunotherapy approved for adjuvant treatment in CSCC, offering a new option for patients at high risk of recurrence.

  4. 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.

  5. 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 …

  6. FDA Approves Cemiplimab as Adjuvant Immunotherapy for High …

    Oct 13, 2025 · 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 …

  7. 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 …

  8. 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 …

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

    Oct 8, 2025 · 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 …

  10. FDA Approval of Cemiplimab: A New Era for High-Risk CSCC Treatment

    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 …