- 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) 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
- 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)
- 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
- 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
- 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 drug for high-risk skin cancer
The FDA has approved cemiplimab-rwlc, marketed as Libtayo, as the first immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma with a high risk of recurrence after surgery and
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