Difference between revisions of "Toripalimab (Loqtorzi)"

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(Created page with "==Mechanism of action== From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/toripalimab NCI Drug Dictionary]: A humanized immunoglobulin (Ig) G4 monoclo...")
 
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From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/toripalimab NCI Drug Dictionary]: A humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, toripalimab binds to PD-1 and inhibits the binding of PD-1 to its 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 the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/toripalimab NCI Drug Dictionary]: A humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, toripalimab binds to PD-1 and inhibits the binding of PD-1 to its 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 established==
===[[Nasopharyngeal carcinoma]]===
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*[[Nasopharyngeal carcinoma]]
# '''JUPITER-02:''' NCT03581786
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==Diseases for which it is used==
 
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*[[Breast cancer, triple negative]]
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*[[Clear cell renal cell carcinoma]]
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*[[Esophageal squamous cell carcinoma]]
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*[[Melanoma]]
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*[[Non-small cell lung cancer, nonsquamous]]
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*[[Non-small cell lung cancer, squamous]]
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*[[Urothelial carcinoma]]
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==History of changes in FDA indication==
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*2023-10-27: Approved with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced [[Nasopharyngeal carcinoma|nasopharyngeal carcinoma (NPC)]]. ''(Based on JUPITER-02)''
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*2023-10-27: Approved as a single agent for adults with recurrent unresectable or metastatic [[Nasopharyngeal carcinoma|NPC]] with disease progression on or after a platinum-containing chemotherapy. ''(Based on POLARIS-02)''
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==History of changes in NMPA indication==
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*2018-12-17: Initial approval
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*2024-04-11: Approved in combination with axitinib for the first-line treatment of patients with medium- to high-risk unresectable or metastatic [[renal cell carcinoma|renal cell carcinoma (RCC)]]. ''(Based on RENOTORCH)''
 
==Also known as==
 
==Also known as==
*'''Code name:''' JS001
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*'''Code names:''' JS-001, TAB-001
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*'''Generic name:''' teriprolizumab, toripalimab-tpzi
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*'''Brand name:''' Loqtorzi, Tuoyi
  
 
[[Category:Drugs]]
 
[[Category:Drugs]]
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[[Category:Anti-PD-1 antibodies]]
 
[[Category:Anti-PD-1 antibodies]]
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[[Category:Breast cancer medications]]
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[[Category:Esophageal squamous cell carcinoma medications]]
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[[Category:Melanoma medications]]
 
[[Category:Nasopharyngeal carcinoma medications]]
 
[[Category:Nasopharyngeal carcinoma medications]]
 
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[[Category:Non-small cell lung cancer, nonsquamous medications]]
[[Category:Investigational drugs]]
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[[Category:Non-small cell lung cancer, squamous medications]]
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[[Category:Urothelial carcinoma medications]]
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[[Category:NMPA approved in 2018]]
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[[Category:FDA approved in 2023]]

Latest revision as of 01:32, 23 May 2024

Mechanism of action

From the NCI Drug Dictionary: A humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, toripalimab binds to PD-1 and inhibits the binding of PD-1 to its 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 established

Diseases for which it is used

History of changes in FDA indication

  • 2023-10-27: Approved with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). (Based on JUPITER-02)
  • 2023-10-27: Approved as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. (Based on POLARIS-02)

History of changes in NMPA indication

  • 2018-12-17: Initial approval
  • 2024-04-11: Approved in combination with axitinib for the first-line treatment of patients with medium- to high-risk unresectable or metastatic renal cell carcinoma (RCC). (Based on RENOTORCH)

Also known as

  • Code names: JS-001, TAB-001
  • Generic name: teriprolizumab, toripalimab-tpzi
  • Brand name: Loqtorzi, Tuoyi