Nivolumab/relatlimab
| Combination of | |
|---|---|
| Nivolumab | Programmed death receptor-1 (PD-1) blocking antibody |
| Relatlimab | Lymphocyte activation gene-3 (LAG-3) blocking antibody |
| Clinical data | |
| Trade names | Opdualag |
| License data | |
| Routes of administration | Intravenous |
| ATC code |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| KEGG | |
Nivolumab/relatlimab, sold under the brand name Opdualag, is a fixed-dose combination medication use to treat melanoma.[3] It contains nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody.[3] It is given by intravenous infusion.[3]
The combination was approved for medical use in the United States in March 2022,[3][5] and in the European Union in September 2022.[4]
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.[3][4]
Society and culture
Legal status
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][6] The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.[6] Opdualag was approved for medical use in the European Union in September 2022.[4]
References
- ^ https://www.tga.gov.au/resources/prescription-medicines-registrations/opdualag-bristol-myers-squibb-australia-pty-ltd
- ^ https://www.tga.gov.au/resources/artg/372783
- ^ 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.
- ^ 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.
- ^ "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.
- ^ 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.
Further reading
- 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.
External links
- "Nivolumab". Drug Information Portal. U.S. National Library of Medicine.
- "Relatlimab". Drug Information Portal. U.S. National Library of Medicine.
- 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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