| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | PD-1 |
| Clinical data | |
| Pronunciation | sem' ip li" mab |
| Trade names | Libtayo |
| Other names | REGN-2810, REGN2810, cemiplimab-rwlc |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a618054 |
| License data |
|
| Pregnancy category |
|
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Elimination half-life | 19 days |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6380H9808N1688O2000S44 |
| Molar mass | 143569.10 g·mol−1 |
Cemiplimab, sold under the brand name Libtayo, is a monoclonal antibody medication for the treatment of squamous cell skin cancer.[7][8] Cemiplimab belongs to a class of drugs that binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway.[6][9]
The most common side effects include fatigue, rash, diarrhea, musculoskeletal pain, and nausea.[7][6]
In September 2018, it was approved by the US Food and Drug Administration (FDA) for treating people with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.[7] It was approved for medical use in the European Union in June 2019.[8] It was approved for medical use in Australia in July 2020.[1]
Cemiplimab is the first FDA approval of a medication specifically for advanced cutaneous squamous cell carcinoma (CSCC).[7]
- ^ a b "Libtayo Australian Prescription Medicine Decision Summary". Therapeutic Goods Administration (TGA). 29 July 2020. Archived from the original on 13 August 2020. Retrieved 16 August 2020.
- ^ "AusPAR: Cemiplimab" (PDF). Therapeutic Goods Administration (TGA). 9 November 2020. Archived from the original (PDF) on 7 June 2021. Retrieved 6 June 2021.
- ^ "TGA eBS - Product and Consumer Medicine Information Licence".
- ^ "Cemiplimab Product information". Health Canada. 25 April 2012. Retrieved 29 May 2022.
- ^ "Summary Basis of Decision (SBD) for Libtayo". Health Canada. 23 October 2014. Retrieved 29 May 2022.
- ^ a b c "Libtayo- cemiplimab-rwlc injection". DailyMed. 25 June 2020. Retrieved 16 August 2020.
- ^ a b c d e "FDA approves first treatment for advanced form of the second most common skin cancer". U.S. Food and Drug Administration. 28 September 2018. Retrieved 7 August 2020.
This article incorporates text from this source, which is in the public domain.
- ^ a b c "Libtayo EPAR". European Medicines Agency (EMA). 24 April 2019. Retrieved 7 August 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ Lee A, Duggan S, Deeks ED (June 2020). "Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma". Drugs. 80 (8): 813–819. doi:10.1007/s40265-020-01302-2. PMID 32306208. S2CID 215804809.
