The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Bristol Myers Squibb’s  fixed-dose combination of nivolumab and relatlimab for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP opinion.

“We are very proud of the role we have played in progressing the treatment of advanced melanoma over the years. As part of our mission to deliver new medicines for patients, we have continued to develop new dual immunotherapy combinations,” says Paul BaRsciano, development lead, relatlimab, Bristol Myers Squibb. “This positive CHMP opinion marks the first step toward the potential approval of the first LAG-3 blocking antibody combination – and the third distinct checkpoint inhibitor for BMS – for advanced melanoma patients in the EU.”

The CHMP opinion is based upon efficacy and safety results from the Phase 2/3 RELATIVITY-047 trial. The trial showed that treatment with the fixed-dose combination of nivolumab and relatlimab more than doubled the median progression-free survival (PFS), including in patients with tumor cell PD-L1 expression <1%, when compared to nivolumab monotherapy—an established standard of care. The proposed indication for the EU is based upon an exploratory analysis of the data in patients with tumor cell PD-L1 expression <1%. No new safety events were identified with the combination when compared to nivolumab monotherapy.

In March, FDA approved the fixed-dose combination of nivolumab and relatlimab as Opdualag™(nivolumab and relatlimab-rmbw) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.