Opdualag is a fixed-dose dual immunotherapy combination treatment of the programmed death-1 (PD-1) inhibitor nivolumab and novel Lymphocyte activation gene-3 (LAG-3)-blocking antibody relatlimab.
The drug is indicated to treat unresectable or metastatic melanoma in adult and paediatric patients aged 12 years or above.
For these patients, the FDA has approved 480mg nivolumab and 160mg relatlimab dose which will be given intravenously every four weeks.
Bristol Myers Squibb global drug development chief medical officer Samit Hirawat said: “While we have made great progress in the treatment of advanced melanoma over the past decade, we are committed to expanding dual immunotherapy treatment options for these patients.
“Inhibiting LAG-3 with relatlimab, in a fixed-dose combination with nivolumab, represents a new treatment approach that builds on our legacy of bringing innovative immunotherapy options to patients.
“The approval of a new medicine that includes our third distinct checkpoint inhibitor marks an important step forward in giving patients more options beyond monotherapy treatment.”
The regulatory approval was based on the data obtained from a global, double-blind, randomised Phase II/III RELATIVITY-047 trial, which was conducted in 714 participants.
In this study, the fixed-dose combination of nivolumab and relatlimab was compared to nivolumab alone in untreated metastatic or unresectable melanoma patients.
The company stated that Opdualag more than doubled median progression-free survival (PFS). The trial also met its primary endpoint.