Class/mechanism: PD-1 antibody. Cemiplimab is a recombinant human monoclonal antibody which binds to the PD-1 receptor on T-cells and blocks its interaction with PD-L1 and PD-L2, which immune system inhibition and facilitates anti-tumor immune response.
Extravasation: no information
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Diseases for which it is established
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 2/9/2021: Approved for patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate. (New disease entity; based on R2810-ONC-1620)
- 2/9/2021: Accelerated approval for patients with metastatic BCC (mBCC) previously treated with a HHI or for whom a HHI is not appropriate. (New disease entity; based on R2810-ONC-1620)
- 9/28/2018: Approved for patients with metastatic cutaneous squamous cell carcinoma (CSCC). (Based on R2810-ONC-1423 and R2810-ONC-1540)
- 9/28/2018: Approved for patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation. (Based on R2810-ONC-1423 and R2810-ONC-1540)
- 2/22/2021: Approved for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) 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. (New disease entity; based on EMPOWER-Lung 1)
- 11/8/2022: Approved in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations. (Based on EMPOWER-Lung 3 part 2)
History of changes in EMA indication
- 6/28/2019: Initial marketing authorization as Libtayo.
Also known as
- Code name: REGN2810
- Generic name: cemiplimab-rwlc
- Brand name: Libtayo