Difference between revisions of "Nivolumab and relatlimab (Opdualag)"

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==Mechanism of action==
 
==Mechanism of action==
From the NCI Drug Dictionary: A monoclonal antibody directed against the inhibitor receptor lymphocyte activation gene-3 (LAG-3), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, relatlimab binds to LAG-3 on tumor infiltrating lymphocytes (TILs). This may activate antigen-specific T lymphocytes and enhance cytotoxic T cell-mediated tumor cell lysis, which leads to a reduction in tumor growth.
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From the NCI Drug Dictionary (for relatlimab): A monoclonal antibody directed against the inhibitor receptor lymphocyte activation gene-3 (LAG-3), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, relatlimab binds to LAG-3 on tumor infiltrating lymphocytes (TILs). This may activate antigen-specific T lymphocytes and enhance cytotoxic T cell-mediated tumor cell lysis, which leads to a reduction in tumor growth.
  
==Preliminary data==
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==Toxicity management==
===[[Melanoma]]===
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*[[Immunotherapy toxicity management]]
#'''RELATIVITY-047:''' Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutiérrez E, Rutkowski P, Gogas HJ, Lao CD, De Menezes JJ, Dalle S, Arance A, Grob JJ, Srivastava S, Abaskharoun M, Hamilton M, Keidel S, Simonsen KL, Sobiesk AM, Li B, Hodi FS, Long GV; RELATIVITY-047 Investigators. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. [https://doi.org/10.1056/nejmoa2109970 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/34986285/ PubMed] NCT03470922
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==Diseases for which it is used==
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*[[Melanoma]]
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==History of changes in FDA indication==
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*2022-03-18: Approved for adult and pediatric patients 12 years of age or older with unresectable or metastatic [[melanoma]]. ''(Based on RELATIVITY-047)''
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==History of changes in EMA indication==
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*2022-09-15: initial authorization for the first line treatment of advanced (unresectable or metastatic) [[melanoma]] in adults and adolescents 12 years of age and older with tumour cell PD L1 expression < 1%.
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==Also known as==
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*'''Code name:''' BMS-986016
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*'''Generic name:''' nivolumab and relatlimab-rmbw
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*'''Brand name:''' Opdualag
  
 
[[Category:Drugs]]
 
[[Category:Drugs]]
 
[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
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[[Category:Anti-PD-1 antibodies]]
 
[[Category:Anti-LAG-3 antibodies]]
 
[[Category:Anti-LAG-3 antibodies]]
 
[[Category:Melanoma medications]]
 
[[Category:Melanoma medications]]
[[Category:Investigational drugs]]
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[[Category:Combination drugs]]
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[[Category:EMA approved in 2022]]
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[[Category:FDA approved in 2022]]

Latest revision as of 14:11, 7 May 2023

Mechanism of action

From the NCI Drug Dictionary (for relatlimab): A monoclonal antibody directed against the inhibitor receptor lymphocyte activation gene-3 (LAG-3), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, relatlimab binds to LAG-3 on tumor infiltrating lymphocytes (TILs). This may activate antigen-specific T lymphocytes and enhance cytotoxic T cell-mediated tumor cell lysis, which leads to a reduction in tumor growth.

Toxicity management

Diseases for which it is used

History of changes in FDA indication

  • 2022-03-18: Approved for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. (Based on RELATIVITY-047)

History of changes in EMA indication

  • 2022-09-15: initial authorization for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD L1 expression < 1%.

Also known as

  • Code name: BMS-986016
  • Generic name: nivolumab and relatlimab-rmbw
  • Brand name: Opdualag