Drug updated on 5/17/2024
| Dosage Form | Injection (intravenous; 350 mg/7 mL) |
| Drug Class | Programmed death receptor-1 (PD-1) blocking antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated 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.
- Indicated 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.
- Indicated, 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.
- Indicated, 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 metastatic.
- Indicated as a 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.
- Indicated as a 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 metastatic.
Latest News
Summary
- Cemiplimab-rwlc (Libtayo) is an immune checkpoint inhibitor that targets the programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) pathway, demonstrating significant effectiveness in treating various cancers including non-small cell lung cancer (NSCLC), cutaneous squamous cell carcinoma (CSCC), and potentially cervical cancer.
- Nine systematic reviews/meta-analyses focused on Libtayo's safety and effectiveness compared to other therapies across various indications, with special attention given to population types and subgroup considerations.
- In comparison with other therapies for NSCLC treatment, Libtayo demonstrated superior overall survival rates and a balanced safety profile in advanced NSCLC patients without PD-L1 selection. It outperformed some other immune checkpoint inhibitors as well as combinations of these inhibitors with platinum-based chemotherapy, presenting less toxicity.
- For cutaneous squamous cell carcinoma treatment, Libtayo showed rapid antitumor efficacy with acceptable safety profiles. It surpassed EGFR inhibitors, pembrolizumab, and platinum-based chemotherapies in terms of overall survival rate and progression-free survival rate when used either as first-line or later treatments.
- The response rates to cemiplimab-rwlc varied among different subgroups based on factors such as PD-L1 expression levels or primary tumor location, indicating potential influences which suggest a need for personalized treatment approaches based on these factors.
- The incidence of adverse events associated with cemiplimab-rwlc was manageable compared to those related to other ICIs; it had a lower cardiotoxicity risk along with generally low rates of discontinuation due to adverse effects, making its safety profile favorable against many others.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Libtayo (cemiplimab-rwlc) Prescribing Information. | 2021 | Regeneron Pharmaceuticals, Tarrytown, NY |