Difference between revisions of "Sintilimab (Tyvyt)"

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From [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/sintilimab NCI Drug Dictionary]: A recombinant human monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (PD-1; PDCD1; PD1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, sintilimab binds to PD-1 and inhibits the binding of PD-1 to the PD-1 ligands programmed cell death-1 ligand 1 (PD-L1), and PD-1 ligand 2 (PD-L2). This prevents the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells.
 
From [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/sintilimab NCI Drug Dictionary]: A recombinant human monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (PD-1; PDCD1; PD1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, sintilimab binds to PD-1 and inhibits the binding of PD-1 to the PD-1 ligands programmed cell death-1 ligand 1 (PD-L1), and PD-1 ligand 2 (PD-L2). This prevents the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells.
  
=Preliminary data=
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==Diseases for which it is used==
===[[Non-small cell lung cancer]]===
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*[[Esophageal squamous cell carcinoma]]
# '''ORIENT-11:''' Yang Y, Wang Z, Fang J, Yu Q, Han B, Cang S, Chen G, Mei X, Yang Z, Ma R, Bi M, Ren X, Zhou J, Li B, Song Y, Feng J, Li J, He Z, Zhou R, Li W, Lu Y, Wang Y, Wang L, Yang N, Zhang Y, Yu Z, Zhao Y, Xie C, Cheng Y, Zhou H, Wang S, Zhu D, Zhang W, Zhang L. Efficacy and Safety of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC: a Randomized, Double-Blind, Phase 3 Study (Oncology pRogram by InnovENT anti-PD-1-11). J Thorac Oncol. 2020 Oct;15(10):1636-1646. Epub 2020 Aug 8. [https://doi.org/10.1016/j.jtho.2020.07.014 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32781263 PubMed] NCT03607539
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*[[Hepatocellular carcinoma]]
 
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*[[Classical Hodgkin lymphoma]]
==History of changes in FDA indication==
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*[[Non-small cell lung cancer]]
''Not FDA-approved at this time; this drug has been approved by the NMPA.''
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**[[Non-small cell lung cancer, nonsquamous]]
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**[[Non-small cell lung cancer, squamous]]
  
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==History of changes in NMPA indication==
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*2018-12-24: Initial approval
 
==Also known as==
 
==Also known as==
*'''Code name:''' IBI 308
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*'''Code name:''' IBI-308
*'''Brand name:''' Tyvyt
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*'''Brand names:''' Daboshu, Tyvyt
  
 
[[Category:Drugs]]
 
[[Category:Drugs]]
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[[Category:Esophageal squamous cell carcinoma medications]]
 
[[Category:Esophageal squamous cell carcinoma medications]]
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[[Category:Hepatocellular carcinoma medications]]
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[[Category:Classical Hodgkin lymphoma medications]]
 
[[Category:Non-small cell lung cancer medications]]
 
[[Category:Non-small cell lung cancer medications]]
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[[Category:Non-small cell lung cancer, nonsquamous medications]]
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[[Category:Non-small cell lung cancer, squamous medications]]
  
[[Category:NMPA approved drugs]]
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[[Category:NMPA approved in 2018]]
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[[Category:PMDA approved drugs]]

Latest revision as of 01:17, 7 November 2023

Mechanism of action

From NCI Drug Dictionary: A recombinant human monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (PD-1; PDCD1; PD1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, sintilimab binds to PD-1 and inhibits the binding of PD-1 to the PD-1 ligands programmed cell death-1 ligand 1 (PD-L1), and PD-1 ligand 2 (PD-L2). This prevents the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells.

Diseases for which it is used

History of changes in NMPA indication

  • 2018-12-24: Initial approval

Also known as

  • Code name: IBI-308
  • Brand names: Daboshu, Tyvyt