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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).
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 Safety & full Prescrib...
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.
FDA label information for this drug is available at DailyMed. Use in Cancer Cemiplimab-rwlc is approved to treat: Basal cell carcinoma (BCC) (a type of skin cancer).
The FDA approval is based on data from the pivotal Phase 3 C-POST trial investigating adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence after surgery and radiation.
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Immune-Mediated Adverse Reactions Advise patients that LIBTAYO can cause immune-mediated adverse reactions including the following [see ...
LIBTAYO® (Lib-TIE-oh) (cemiplimab-rwlc) injection What is the most important information I should know about LIBTAYO? LIBTAYO is a medicine that may treat certain types of cancers by working with your immune system. L...
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 regulato...
On November 8, 2022, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for adult patients with ...
