Description
What is Libtayo (cemiplimab)?
Libtayo (cemiplimab) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with:
- Metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. [3].
- Advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate.[]
- Advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%). Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations.[]
How does Libtayo (cemiplimab) work?
Libtayo (cemiplimab) is a fully-human monoclonal antibody that targets the immune checkpoint receptor PD-1 (programmed cell death protein-1), a protein found on the body’s immune cells and some cancer cells. As a result of the inhibition of the PD-1 pathway, T-cell receptor signaling can be reactivated and antitumor activity can be restored. By blocking this cellular pathway, the drug may help the body’s immune system fight the cancer cells[1].
Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumours and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumours[1].
Where has Libtayo (cemiplimab) been approved?
Libtayo (cemiplimab) was approved by:
- Food and Drug Administration (FDA), US:
- European Medical Agency (EMA), European Union
- June 28, 2019 for advanced BCC [4]
- Health Canada, Canada:
- April 10, 2019 for advanced BCC[5]
It is the first treatment that is FDA-approved specifically for advanced CSCC. The medicine was approved under Priority Review, which is reserved for medicines that represent significant improvements in safety or efficacy in treating serious conditions, and it was granted Breakthrough Therapy Designation status for advanced CSCC.[3]
Currently, the EMA is assessing Libtayo (cemiplimab) in both advanced NSCLC and locally advanced BCC, and decisions from the EMA are expected in mid-2021.[7]
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Libtayo (cemiplimab) taken?
The recommended dosage is[1]:
- 350 mg, every 3 weeks, intravenous infusion over 30 minutes
Adjustment in dose may be required based on symptoms and experienced side effects[1].
Complete information about Libtayo (cemiplimab) dosage and administration can be found in the official prescribing information listed in our resources section.[1]
Note: Please consult with your treating doctor for personalised dosing.
Are there any known side effects or adverse reactions of Libtayo (cemiplimab)?
Early identification and management are essential to ensure safe use of PD-1 blocking antibodies. Monitor for symptoms and signs of immune-mediated adverse reactions. Evaluate clinical chemistries, including liver and thyroid function, at baseline and periodically during treatment. Withhold or permanently discontinue Libtayo (cemiplimab) and administer corticosteroids based on the severity of reaction. See official prescribing information listed in our resources section[1].
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