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  • 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) FDA Approval History - Drugs. com
    Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), and non-small cell lung cancer (NSCLC)
  • 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
  • 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
  • Libtayo® (cemiplimab-rwlc) Approved in the U. S. as First and . . .
    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 An additional regulatory application is also under review in the European Union, with a decision expected by the first half of 2026
  • 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 Cemiplimab as First, Only Adjuvant Immunotherapy . . .
    Cemiplimab is the first immunotherapy approved for adjuvant treatment in CSCC, offering a new option for patients at high risk of recurrence
  • 2025 FDA added indications to dermatologic medications
    In October 2025, the FDA approved Libtayo (cemiplimab) as a treatment for cutaneous squamous cell carcinoma that has a high risk of recurring after it has been treated with surgery and radiation
  • FDA Approvals in Oncology: October-December 2025
    Cemiplimab (Libtayo) was approved for use after surgery and adjuvant radiation in patients whose cutaneous squamous cell carcinoma (CSCC)—one of the most common forms of skin cancer—has a high risk of recurring
  • Cemiplimab Becomes First Treatment Approved for Advanced . . .
    On Friday, September 28, 2018, the U S Food and Drug Administration approved cemiplimab (Libtayo®, Regeneron and Sanofi) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) as well as patients with locally advanced CSCC for whom surgery or radiation is not applicable





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