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Nivolumab/relatlimab

From Wikipedia, the free encyclopedia
Combination drug

Pharmaceutical compound
Nivolumab/relatlimab
Combination of
NivolumabProgrammed death receptor-1 (PD-1) blocking antibody
RelatlimabLymphocyte activation gene-3 (LAG-3) blocking antibody
Clinical data
Trade namesOpdualag
AHFS/Drugs.comMonograph
MedlinePlusa622037
License data
Routes of
administration
Intravenous
ATC code
Legal status
Legal status
Identifiers
KEGG

Nivolumab/relatlimab, sold under the brand nameOpdualag, is afixed-dose combination medication use to treatmelanoma.[10] It containsnivolumab, aprogrammed death receptor-1 (PD-1) blocking antibody, andrelatlimab, alymphocyte activation gene-3 (LAG-3) blocking antibody.[10] It is given byintravenous infusion.[10]

The combination was approved for medical use in the United States in March 2022,[10][12] and in the European Union in September 2022.[11] The USFood and Drug Administration (FDA) considers it to be afirst-in-class medication.[13][14]

Medical uses

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The combination isindicated for the first line treatment of advanced (unresectable or metastatic) melanoma in people aged twelve years of age and older.[10][11]

It is also currently being researched as a possible treatment forParkinson's disease and other neurodegenerative conditions, based on early evidence that it may prevent the spread of pathologically misfoldedalpha-synuclein protein (Lewy bodies) through neurons in thesubstantia nigra region of the brain.[15]

Society and culture

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Legal status

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In July 2022, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Opdualag, intended for the treatment of melanoma.[11][16] The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.[16] Opdualag was approved for medical use in the European Union in September 2022.[11][17]

In January 2024, theNational Institute for Health and Care Excellence (NICE) recommended nivolumab-relatlimab[18] as a first-line treatment ofadvanced melanoma in patients aged 12 years and older.[19]

References

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  1. ^"Opdualag (Bristol-Myers Squibb Australia Pty Ltd)".Therapeutic Goods Administration (TGA). 11 November 2022.Archived from the original on 22 November 2022. Retrieved29 April 2023.
  2. ^"Opdualag nivolumab 240mg and relatlimab 80mg in 20mL concentrate solution for IV infusion vial (372783)".Therapeutic Goods Administration (TGA). 8 October 2022.Archived from the original on 22 November 2022. Retrieved29 April 2023.
  3. ^"AusPAR: Opdualag".Therapeutic Goods Administration (TGA). 2 January 2024. Retrieved31 March 2024.
  4. ^"Details for: Opdualag".Health Canada. 13 September 2023. Retrieved3 March 2024.
  5. ^"Notice: Multiple additions to the Prescription Drug List (PDL) [2023-12-22]".Health Canada. 22 December 2023.Archived from the original on 3 January 2024. Retrieved3 January 2024.
  6. ^"Summary Basis of Decision (SBD) for Opdualag".Health Canada. 21 December 2023. Retrieved17 January 2024.
  7. ^"Details for: Opdualag".Health Canada. 13 September 2023. Retrieved17 January 2024.
  8. ^"Archived copy".Archived from the original on 8 January 2024. Retrieved8 January 2024.{{cite web}}: CS1 maint: archived copy as title (link)
  9. ^"Opdualag licensed for patients with advanced melanoma".Medicines and Healthcare products Regulatory Agency (MHRA) (Press release). 27 December 2023.Archived from the original on 8 January 2024. Retrieved8 January 2024.
  10. ^abcdef"Opdualag- nivolumab and relatlimab-rmbw injection".DailyMed. 18 March 2022.Archived from the original on 30 July 2022. Retrieved22 March 2022.
  11. ^abcde"Opdualag EPAR".European Medicines Agency. 18 July 2022.Archived from the original on 22 September 2022. Retrieved22 September 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  12. ^"U.S. Food and Drug Administration Approves First LAG-3-Blocking Antibody Combination, Opdualag (nivolumab and relatlimab-rmbw), as Treatment for Patients with Unresectable or Metastatic Melanoma" (Press release).Bristol Myers Squibb. 18 March 2022.Archived from the original on 19 March 2022. Retrieved19 March 2022 – via Business Wire.
  13. ^"Advancing Health Through Innovation: New Drug Therapy Approvals 2022".U.S.Food and Drug Administration (FDA). 10 January 2023. Archived fromthe original on 21 January 2023. Retrieved22 January 2023.Public Domain This article incorporates text from this source, which is in thepublic domain.
  14. ^New Drug Therapy Approvals 2022.U.S.Food and Drug Administration (FDA) (Report). January 2024. Archived fromthe original(PDF) on 14 January 2024. Retrieved14 January 2024.Public Domain This article incorporates text from this source, which is in thepublic domain.
  15. ^Dyer R (21 October 2025)."Parkinson's Discovery Suggests We May Have an FDA-Approved Treatment Already".ScienceAlert. Retrieved21 October 2025.
  16. ^ab"Opdualag: Pending EC decision".European Medicines Agency. 21 July 2022.Archived from the original on 28 July 2022. Retrieved30 July 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  17. ^"Opdualag Product information".Union Register of medicinal products. 12 December 2022.Archived from the original on 20 September 2022. Retrieved3 March 2023.
  18. ^"Comparative Efficacy and Safety of Anticancer Medication Assessed by Analysis Group Researchers".www.analysisgroup.com. Retrieved21 April 2025.
  19. ^"Bristol Myers Squibb's Opdualag recommended by NICE for advanced melanoma".PMLive. 10 January 2024.Archived from the original on 11 January 2024. Retrieved11 January 2024.

Further reading

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External links

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  • Clinical trial numberNCT03470922 for "A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma (RELATIVITY-047)" atClinicalTrials.gov
CImonoclonal antibodies ("-mab")
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