Wikipedia

Nivolumab/relatlimab

Nivolumab/relatlimab, sold under the brand name Opdualag, is a fixed-dose combination medication use to treat melanoma.[10] It contains nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody.[10] It is given by intravenous infusion.[10]

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

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 US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[13][14]

Medical uses

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

Society and culture

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In July 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European 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][15] The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.[15] Opdualag was approved for medical use in the European Union in September 2022.[11][16]

In January 2024, the National Institute for Health and Care Excellence (NICE) recommended nivolumab-relatlimab) as a first-line treatment of advanced melanoma in patients aged 12 years and older.[17]

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. Retrieved 29 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. Retrieved 29 April 2023.
  3. ^ "AusPAR: Opdualag". Therapeutic Goods Administration (TGA). 2 January 2024. Retrieved 31 March 2024.
  4. ^ "Details for: Opdualag". Health Canada. 13 September 2023. Retrieved 3 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. Retrieved 3 January 2024.
  6. ^ "Summary Basis of Decision (SBD) for Opdualag". Health Canada. 21 December 2023. Retrieved 17 January 2024.
  7. ^ "Details for: Opdualag". Health Canada. 13 September 2023. Retrieved 17 January 2024.
  8. ^ "Archived copy". Archived from the original on 8 January 2024. Retrieved 8 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. Retrieved 8 January 2024.
  10. ^ a b c d e f "Opdualag- nivolumab and relatlimab-rmbw injection". DailyMed. 18 March 2022. Archived from the original on 30 July 2022. Retrieved 22 March 2022.
  11. ^ a b c d e "Opdualag EPAR". European Medicines Agency. 18 July 2022. Archived from the original on 22 September 2022. Retrieved 22 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. Retrieved 19 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 from the original on 21 January 2023. Retrieved 22 January 2023.   This article incorporates text from this source, which is in the public domain.
  14. ^ New Drug Therapy Approvals 2022 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 14 January 2024. Retrieved 14 January 2024.   This article incorporates text from this source, which is in the public domain.
  15. ^ a b "Opdualag: Pending EC decision". European Medicines Agency. 21 July 2022. Archived from the original on 28 July 2022. Retrieved 30 July 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  16. ^ "Opdualag Product information". Union Register of medicinal products. 12 December 2022. Archived from the original on 20 September 2022. Retrieved 3 March 2023.
  17. ^ "Bristol Myers Squibb's Opdualag recommended by NICE for advanced melanoma". PMLive. 10 January 2024. Archived from the original on 11 January 2024. Retrieved 11 January 2024.

Further reading

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  • Clinical trial number NCT03470922 for "A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma (RELATIVITY-047)" at ClinicalTrials.gov


 

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