Cemiplimab (Libtayo)
General information
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.[1][2][3]
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 9/28/2018: FDA approved for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
- 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.
- 2/9/2021: Accelerated approval for patients with metastatic BCC (mBCC) previously treated with a HHI or for whom a HHI is not appropriate.
Also known as
- Code name: REGN2810
- Generic name: cemiplimab-rwlc
- Brand name: Libtayo