Nivolumab/relatlimab explained

Type:combo
Component1:Nivolumab
Class1:Programmed death receptor-1 (PD-1) blocking antibody
Component2:Relatlimab
Class2:Lymphocyte activation gene-3 (LAG-3) blocking antibody
Tradename:Opdualag
Dailymedid:Nivolumab and relatlimab
Routes Of Administration:Intravenous
Atc Prefix:L01
Atc Suffix:FY02
Legal Au:S4
Legal Au Comment:[1] [2] [3]
Legal Ca:Rx-only
Legal Ca Comment:[4] [5] [6] [7]
Legal Uk:POM
Legal Uk Comment:[8] [9]
Legal Us:Rx-only
Legal Us Comment:[10]
Legal Eu:Rx-only
Legal Eu Comment:[11]
Kegg:D12334

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

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

Medical uses

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

Society and culture

Legal status

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. 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.[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]

Further reading

Notes and References

  1. Web site: Opdualag (Bristol-Myers Squibb Australia Pty Ltd) . Therapeutic Goods Administration (TGA) . 11 November 2022 . 29 April 2023 . 22 November 2022 . https://web.archive.org/web/20221122020608/https://www.tga.gov.au/resources/prescription-medicines-registrations/opdualag-bristol-myers-squibb-australia-pty-ltd . live .
  2. Web site: Opdualag nivolumab 240mg and relatlimab 80mg in 20mL concentrate solution for IV infusion vial (372783) . Therapeutic Goods Administration (TGA) . 8 October 2022 . 29 April 2023 . 22 November 2022 . https://web.archive.org/web/20221122020608/https://www.tga.gov.au/resources/artg/372783 . live .
  3. Web site: AusPAR: Opdualag . Therapeutic Goods Administration (TGA) . 2 January 2024 . 31 March 2024.
  4. Web site: Details for: Opdualag . . 13 September 2023 . 3 March 2024.
  5. Web site: Notice: Multiple additions to the Prescription Drug List (PDL) [2023-12-22] ]. . 22 December 2023 . 3 January 2024 . 3 January 2024 . https://web.archive.org/web/20240103055619/https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2023-12-22.html . live .
  6. Web site: Summary Basis of Decision (SBD) for Opdualag . . 21 December 2023 . 17 January 2024.
  7. Web site: Details for: Opdualag . . 13 September 2023 . 17 January 2024.
  8. Web site: Archived copy . 8 January 2024 . 8 January 2024 . https://web.archive.org/web/20240108044312/https://mhraproducts4853.blob.core.windows.net/docs/8a7469dd1d8d2add02dfc2f3592332edf11b9e4b . live .
  9. Opdualag licensed for patients with advanced melanoma . Medicines and Healthcare products Regulatory Agency (MHRA) . 27 December 2023 . 8 January 2024 . 8 January 2024 . https://web.archive.org/web/20240108044309/https://www.gov.uk/government/news/opdualag-licensed-for-patients-with-advanced-melanoma . live .
  10. Web site: Opdualag- nivolumab and relatlimab-rmbw injection . DailyMed . 18 March 2022 . 22 March 2022 . 30 July 2022 . https://web.archive.org/web/20220730051313/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b22c9d83-3256-4e17-85f7-f331a504adc6 . live .
  11. Web site: Opdualag EPAR . European Medicines Agency . 18 July 2022 . 22 September 2022 . 22 September 2022 . https://web.archive.org/web/20220922161306/https://www.ema.europa.eu/en/medicines/human/EPAR/opdualag . live . 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 . . Business Wire . 18 March 2022 . 19 March 2022 . 19 March 2022 . https://web.archive.org/web/20220319212135/https://www.businesswire.com/news/home/20220304005561/en/U.S.-Food-and-Drug-Administration-Approves-First-LAG-3-Blocking-Antibody-Combination-Opdualag%E2%84%A2-nivolumab-and-relatlimab-rmbw-as-Treatment-for-Patients-with-Unresectable-or-Metastatic-Melanoma . live .
  13. Web site: Advancing Health Through Innovation: New Drug Therapy Approvals 2022 . U.S. Food and Drug Administration (FDA) . 10 January 2023 . 22 January 2023 . 21 January 2023 . https://web.archive.org/web/20230121035714/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022 . live .
  14. New Drug Therapy Approvals 2022 . U.S. Food and Drug Administration (FDA) . January 2024 . PDF . 14 January 2024 . https://web.archive.org/web/20240114065648/https://www.fda.gov/media/164429/download . 14 January 2024 . live .
  15. Web site: Opdualag: Pending EC decision . European Medicines Agency . 21 July 2022 . 30 July 2022 . 28 July 2022 . https://web.archive.org/web/20220728183647/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/opdualag . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  16. Web site: Opdualag Product information . Union Register of medicinal products . 12 December 2022 . 3 March 2023 . 20 September 2022 . https://web.archive.org/web/20220920170350/https://ec.europa.eu/health/documents/community-register/html/h1679.htm . live .
  17. Web site: 2024-01-10 . Bristol Myers Squibb's Opdualag recommended by NICE for advanced melanoma . 2024-01-11 . PMLive . en . 11 January 2024 . https://web.archive.org/web/20240111102217/https://www.pmlive.com/pharma_news/bristol_myers_squibbs_opdualag_recommended_by_nice_for_advanced_melanoma_1506189 . live .

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