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) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH of 6.

Oct 29, 2025 · These highlights do not include all the information needed to use LIBTAYO safely and effectively. See full prescribing information for LIBTAYO. LIBTAYO® (cemiplimab-rwlc) injection, for ...

TARRYTOWN, N.Y., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has …

Oct 9, 2025 · FDA approval history for Libtayo (cemiplimab-rwlc) used to treat Squamous Cell Carcinoma, Basal Cell Carcinoma, Non Small Cell Lung Cancer. Supplied by Sanofi

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 …

The recommended cemiplimab-rwlc dose and schedule is 350 mg as an intravenous infusion over 30 minutes every 3 weeks. View full prescribing information for LIBTAYO.

Aug 16, 2025 · FAQ What type of drug is Cemiplimab? Cemiplimab is a fully human monoclonal antibody and an immune checkpoint inhibitor. It blocks the PD-1 receptor on T cells, helping the …

On February 9, 2021, the Food and Drug Administration granted regular approval to cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for patients with locally advanced basal cell carcinoma ...

Overview This document addresses the use of Libtayo (cemiplimab). Libtayo (cemiplimab) is a programmed death receptor-1 (PD-1) blocking antibody used to treat cutaneous squamous cell …