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 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a622037 |
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.[8] It contains nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody.[8] It is given by intravenous infusion.[8]
The combination was approved for medical use in the United States in March 2022,[8][10] and in the European Union in September 2022.[9] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[11][12]
The combination is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in people aged twelve years of age and older.[8][9]
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.[9][13] The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.[13] Opdualag was approved for medical use in the European Union in September 2022.[9][14]
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.[15]