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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 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) - OHSU
Used as continuation maintenance therapy in patients who have achieved a tumor response or stable disease after first-line therapy with cemiplimab, pemetrexed, and either carboplatin or cisplatin for non-squamous cell histology; OR
- Regeneron Receives FDA Approval for Libtayo; 68% Risk . . .
Regeneron (NASDAQ: REGN) announced FDA approval of Libtayo (cemiplimab-rwlc) as the first and only immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation, approved Oct 8, 2025 Approval was based on Phase 3 C-POST results showing a 68% reduction in risk of disease recurrence or death versus placebo (HR 0 32; 95%
- 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
- LIBTAYO® (cemiplimab-rwlc) in Advanced NSCLC, BCC, CSCC . . .
Learn about LIBTAYO® (cemiplimab-rwlc) in the treatment of advanced NSCLC, BCC, CSCC, as an adjuvant treatment for high-risk CSCC Review Important Safety Info Full Prescribing Information including Med Guide
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