Nivolumab/relatlimab

Nivolumab/relatlimab
Combination of
NivolumabProgrammed death receptor-1 (PD-1) blocking antibody
RelatlimabLymphocyte activation gene-3 (LAG-3) blocking antibody
Names
Trade namesOpdualag
Clinical data
Main usesMelanoma[1]
Side effectsMuscle pain, tiredness, rash, itchiness,diarrhea[1]
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Routes of
use		Intravenous
Legal
License data
Legal status

Nivolumab/relatlimab, sold under the brand name Opdualag, is a combination medication use to treat melanoma.[1] It is used in cases that cannot be treated by surgery alone and have PD-L1 expression of less than 1%.[1][5] It is given by gradual injection into a vein.[1]

Common side effects include muscle pain, tiredness, rash, itchiness, and diarrhea.[1] Other side effects may include immune-mediated disorders such as pneumonitis and colitis; and infusion reactions.[1] Use during pregnancy may harm the baby.[1] It contains two monoclonal antibodies; nivolumab, a programmed death receptor-1 (PD-1) blocker, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocker.[1][4]

The combination was approved for medical use in the United States and Europe in 2022.[1][4] It is not approved in the United Kingdom as of 2022.[5] In the United States it costs about 29,000 USD every 4 weeks as of 2022.[6]

Medical uses

The combination is indicated for a first line treatment of advanced (unresectable or metastatic) melanoma in people aged twelve years of age and older.[1][4]

Dosage

In those who weight at least 40 kg the dose is 480 mg nivolumab and 160 mg relatlimab every 4 weeks.[1]

Society and culture

On 21 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.[4][7] The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.[7] Opdualag was approved for medical use in the European Union in September 2022.[4]

References

  1. 1 2 3 4 5 6 7 8 9 10 11 12 13 "Opdualag- nivolumab and relatlimab-rmbw injection". DailyMed. 18 March 2022. Archived from the original on 30 July 2022. Retrieved 22 March 2022.
  2. ↑ "Archive copy". Archived from the original on 2022-11-22. Retrieved 2022-11-22.{{cite web}}: CS1 maint: archived copy as title (link)
  3. ↑ "Archive copy". Archived from the original on 2022-11-22. Retrieved 2022-11-22.{{cite web}}: CS1 maint: archived copy as title (link)
  4. 1 2 3 4 5 6 "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.
  5. 1 2 "Relatlimab + nivolumab". SPS - Specialist Pharmacy Service. 27 April 2018. Archived from the original on 12 August 2022. Retrieved 12 December 2022.
  6. ↑ "Opdualag Prices, Coupons, Copay & Patient Assistance". Drugs.com. Retrieved 12 December 2022.
  7. 1 2 "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.
Identifiers:
  • "Nivolumab". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2022-08-09. Retrieved 2022-11-22.
  • "Relatlimab". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2022-08-15. Retrieved 2022-11-22.
  • Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutiérrez E, et al. (January 2022). "Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma". N Engl J Med. 386 (1): 24–34. doi:10.1056/NEJMoa2109970. PMID 34986285. S2CID 245771473.
  • 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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