Difference between revisions of "Sintilimab (Tyvyt)"

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m (Jwarner moved page Sintilimab (IBI 308) to Sintilimab (Tyvyt): Approval)
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[[Category:Anti-PD-1 antibodies]]
 
[[Category:Anti-PD-1 antibodies]]
  
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[[Category:Esophageal squamous cell carcinoma medications]]
 
[[Category:Non-small cell lung cancer medications]]
 
[[Category:Non-small cell lung cancer medications]]
  
 
[[Category:NMPA approved drugs]]
 
[[Category:NMPA approved drugs]]

Revision as of 02:04, 1 May 2022

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.

Preliminary data

Non-small cell lung cancer

  1. 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. link to original article PubMed NCT03607539

History of changes in FDA indication

Not FDA-approved at this time; this drug has been approved by the NMPA.

Also known as

  • Code name: IBI 308
  • Brand name: Tyvyt