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  • FDA approves cemiplimab-rwlc in combination with platinum . . .
    On November 8, 2022, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc ) in combination with platinum-based chemotherapy for adult patients with
  • label - Food and Drug Administration
    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)
  • 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)
  • 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 Cutaneous Squamous Cell Carcinoma . . .
    The Food and Drug Administration (FDA) has approved Libtayo (cemiplimab-rwlc) for the adjuvant, or postsurgical, treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation, the agency has announced Effectiveness of the drug was determined in the C-POST randomized, double-blind, multicenter, placebo-controlled trial of 415 patients
  • FDA Approves Cemiplimab (Libtayo) for Cutaneous Squamous Cell . . .
    The U S Food and Drug Administration approved adjuvant cemiplimab (Libtayo) for adults with cutaneous squamous cell carcinoma who are at a high risk for recurrence after surgery and radiation
  • FDA Approves Cemiplimab-Rwlc for Adjuvant Treatment of . . .
    The following is a message from the Director of the FDA Oncology Center of Excellence, Dr Richard Pazdur: 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
  • FDA Approves Immunotherapy for Cutaneous Squamous-cell . . .
    THE FOOD AND DRUG ADMINISTRATION (FDA) approved the immunotherapy Libtayo (cemiplimab) for high-risk cutaneous squamous-cell carcinoma (CSCC), a common skin cancer type The Oct 8, 2025, approval was based on findings that people given Libtayo after surgery and radiation lived longer without their disease recurring—a measure known as disease-free survival—compared with those treated with
  • 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
  • Regeneron gests US FDA approval for Libtayo as an adjuvant . . .
    Regeneron Pharmaceuticals, Inc announced that the US Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation The FDA





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