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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
- REGN Gets EC Nod for Libtayo Label Expansion, FDA Clears . . .
Regeneron gains EC approval to expand Libtayo's use in high-risk CSCC The FDA approves Eylea HD the treatment of patients with macular edema following retinal vein occlusion
- FDA Approves Cemiplimab as Adjuvant Treatment for Cutaneous . . .
Cemiplimab's approval is supported by findings from the C-POST clinical trial The FDA approved cemiplimab-rwlc (Libtayo; Regeneron Pharmaceuticals) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) who are at a high risk of recurrence following surgery and radiation
- 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 “more favorable” than Keytruda for first-line . . .
The FDA approved Libtayo in 2022 as a first-line treatment for advanced NSCLC, in combination with chemotherapy However, it has been unclear whether this new combination treatment could outperform Keytruda plus chemotherapy from a cost-effectiveness standpoint
- Libtayo (cemiplimab-rwlc) - OHSU
Patients previously presenting with aggressive disease who are exhibiting stable disease on treatment as their best response (or if therapy improved performance status) may be eligible for continued therapy without interruption or discontinuation
- Cemiplimab (Libtayo): A Patient Guide for 2025 to Treatment . . .
Cemiplimab is a newer cancer treatment that has brought hope to patients with advanced skin and lung cancers It is part of an exciting group of drugs called immune checkpoint inhibitors, which help the body’s immune system fight cancer more effectively Cemiplimab is approved by the U S Food and Drug Administration (FDA) to treat advanced forms of skin cancers, including cutaneous squamous
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