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Libtayo (cemiplimab-rwlc) FDA Approval History - Drugs. com Libtayo FDA Approval History Last updated by Judith Stewart, BPharm on Oct 9, 2025 FDA Approved: Yes (First approved September 28, 2018) Brand name: Libtayo Generic name: cemiplimab-rwlc Dosage form: Injection Company: Sanofi Treatment for: Squamous Cell Carcinoma, Basal Cell Carcinoma, Non Small Cell Lung Cancer Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking
Behind the FDA Approval: Adjuvant Cemiplimab Shifts Treatment . . . Vishal A Patel, MD, discusses the FDA approval of cemiplimab in cutaneous squamous cell carcinoma On October 8, 2025, the US FDA approved the immunotherapy cemiplimab-rwlc (Libtayo) for adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence
Libtayo (cemiplimab-rwlc) - OHSU Other treatment options including, but are not limited to, the following may be appropriate: radiation therapy, surgery, traditional chemotherapy (e g , platinum, taxane), compassionate use expanded access programs, clinical trials, supportive care, integrative and complementary therapies
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
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
FDA Approval of Cemiplimab: A New Era for High-Risk CSCC . . . In a significant step forward for skin cancer management, the U S Food and Drug Administration (FDA) has approved cemiplimab-rwlc (Libtayo) as an adjuvant treatment for adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence following surgery and radiation The decision, announced on October 8, 2025, marks the first approval of a PD-1 inhibitor for this specific post
FDA Approves Libtayo to Help Prevent Return of High-Risk Skin . . . The FDA has approved cemiplimab-rwlc (Libtayo) as a new treatment option to help prevent cutaneous squamous cell carcinoma (CSCC) from returning after surgery and radiation This approval brings hope to adults with CSCC who are at high risk of the cancer coming back, offering another way to lower the chances of recurrence Who Can Benefit? This new approval is intended for patients who have
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