Libtayo

(Cemiplimab-rwlc)

Libtayo

Drug updated on 11/16/2023

Dosage FormInjection (intravenous; 350 mg/7 mL)
Drug ClassProgrammed death receptor-1 blocking antibodies
Ongoing and Completed StudiesClinicalTrials.gov

Indication

  • For the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
  • For the treatment of patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.
  • In combination with platinum-based chemotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
  • As single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

Product Monograph / Prescribing Information

Document TitleYearSource
Libtayo (cemiplimab-rwlc) Prescribing Information.2021Regeneron Pharmaceuticals, Tarrytown, NY

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparison of the profiles of first-line PD-1/PD-L1 inhibitors for advanced NSCLC lacking driver gene mutations: a systematic review and Bayesian network meta-analysis. 2023Therapeutic advances in Chronic Diseases
The effect of gender on the clinical outcome of PD-1/PD-L1 inhibitor in advanced lung cancer patients.2023Medicine
Efficacy and safety of immune checkpoint inhibitors for advanced non-small cell lung cancer with or without PD-L1 selection: A systematic review and network meta-analysis. 2023Chinese Medical Journal
Cardiotoxicity of lung cancer-related immunotherapy versus chemotherapy: a systematic review and network meta-analysis of randomized controlled trials. 2023Frontiers in Oncology
Identifying optimal first-line immune checkpoint inhibitors based regiments for advanced non-small cell lung cancer without oncogenic driver mutations: A systematic review and network meta-analysis. 2023PLoS One
Immune checkpoint inhibitors in advanced cutaneous squamous cell carcinoma: A systemic review and meta-analysis. 2023Skin Research and Technology
Clinical and pharmacoeconomic combined report: cemiplimab (Libtayo) for basal cell carcinoma. 2022CADTH
Clinical and pharmacoeconomic combined report: cemiplimab (Libtayo) for non-small cell lung cancer. 2022CADTH
Population pharmacokinetic models of anti-PD-1 mAbs in patients with multiple tumor types: a systematic review.2022Frontiers in Immunology
Beyond platinum, ICIs in metastatic cervical cancer: a systematic review.2022Cancers
Beyond Platinum, ICIs in Metastatic Cervical Cancer: A Systematic Review. 2022Cancers
PD-(L)1 inhibitors as monotherapy for the first-line treatment of non-small-cell lung cancer patients with high pd-l1 expression: a network meta-analysis.2021Journal of Clinical Medicine
Cemiplimab in advanced cutaneous squamous cell carcinoma. 2021Dermatologic Therapy
Final clinical guidance report: cemiplimab (Libtayo) for cutaneous squamous cell carcinoma. 2020CADTH
Comparative efficacy of cemiplimab versus other systemic treatments for advanced cutaneous squamous cell carcinoma.2020Future Oncology

Clinical Practice Guidelines