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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
    FDA approval history for Libtayo (cemiplimab-rwlc) used to treat Squamous Cell Carcinoma, Basal Cell Carcinoma, Non Small Cell Lung Cancer Supplied by Sanofi
  • 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 for Adjuvant Cutaneous Squamous Cell . . .
    The US FDA has approved the supplemental biologics license application (sBLA) for cemiplimab-rwlc (Libtayo) as adjuvant treatment in adults with high-risk cutaneous squamous cell carcinoma (CSCC) 1 The sBLA approval was based on an extensive review of data from the pivotal phase 3 C-POST study (NCT03969004) which demonstrated a statistically significant and clinically meaningful improvement
  • FDA Approves Libtayo for Adjuvant Treatment of High-Risk CSCC
    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 ® (cemiplimab-rwlc) for the
  • 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
  • Libtayo Gains FDA Approval for Adjuvant CSCC Treatment
    On October 8, 2025, Regeneron Pharmaceuticals announced that the U S Food and Drug Administration (FDA) approved Libtayo (cemiplimab-rwlc), a PD-1 inhibitor, as the first and only immunotherapy for adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence following surgery and radiation This approval, evaluated under Priority Review, is
  • 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 Cemiplimab as First, Only Adjuvant Immunotherapy . . .
    Cemiplimab (Libtayo; Regeneron Pharmaceuticals) has been approved as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) who are at high risk of recurrence after
  • FDA approves cemiplimab-rwlc for locally advanced and . . .
    All patients received cemiplimab-rwlc 350 mg every 3 weeks for up to 93 weeks until disease progression, unacceptable toxicity, or completion of planned treatment





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