Difference between revisions of "Cemiplimab (Libtayo)"

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From [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pd-1-monoclonal-antibody-regn2810 NCI Drug Dictionary]: A human monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (PD-1, PCD-1) protein, with potential immune checkpoint inhibitory and antineoplastic activity. Upon administration, cemiplimab binds to PD-1, inhibits its binding to the PD-1 ligand programmed cell death-1 ligand 1 (PD-L1), and prevents the activation of its downstream signaling pathways.  
 
From [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pd-1-monoclonal-antibody-regn2810 NCI Drug Dictionary]: A human monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (PD-1, PCD-1) protein, with potential immune checkpoint inhibitory and antineoplastic activity. Upon administration, cemiplimab binds to PD-1, inhibits its binding to the PD-1 ligand programmed cell death-1 ligand 1 (PD-L1), and prevents the activation of its downstream signaling pathways.  
  
=Preliminary data=
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==Diseases for which it is used==
===[[Cutaneous squamous cell carcinoma]]===
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*[[Cutaneous squamous cell carcinoma]]
* Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. Epub 2018 Jun 4. [https://www.nejm.org/doi/full/10.1056/NEJMoa1805131 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/29863979 PubMed]
 
  
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==History of changes in FDA indication==
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*9/28/2018: Initial approval "for patients with [[Cutaneous squamous cell carcinoma|metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC]] who are not candidates for curative surgery or curative radiation."
 
==Also known as==
 
==Also known as==
 
*'''Code name:''' REGN2810
 
*'''Code name:''' REGN2810
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*'''Generic name:''' cemiplimab-rwlc
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*'''Brand name:''' Libtayo
  
 
[[Category:Drugs]]
 
[[Category:Drugs]]
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[[Category:Anti-PD-1 antibodies]]
 
[[Category:Anti-PD-1 antibodies]]
  
[[Category:Investigational]]
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[[Category:Cutaneous squamous cell carcinoma medications]]
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[[Category:FDA approved in 2018]]

Revision as of 15:39, 2 October 2018

Mechanism of action

From NCI Drug Dictionary: A human monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (PD-1, PCD-1) protein, with potential immune checkpoint inhibitory and antineoplastic activity. Upon administration, cemiplimab binds to PD-1, inhibits its binding to the PD-1 ligand programmed cell death-1 ligand 1 (PD-L1), and prevents the activation of its downstream signaling pathways.

Diseases for which it is used

History of changes in FDA indication

Also known as

  • Code name: REGN2810
  • Generic name: cemiplimab-rwlc
  • Brand name: Libtayo