The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced the approval of Bristol Myers Squibb’s Opdualag (nivolumab and relatlimab) for advanced melanoma on 27 December.

The regulatory agency authorised Opdualag through Project Orbis. The project is a global collaboration between the MHRA, the Therapeutics Goods Administration in Australia, Health Canada, the Health Sciences Authority in Singapore, Swissmedic, Agência Nacional de Vigilância Sanitária in Brazil and Israel’s Ministry of Health, coordinated by the US Food and Drug Administration (FDA). The regulatory partnership assesses and approves oncology drugs to bring access to treatments faster.

The recent approval was made based on positive data from the Phase II/III RELATIVITY-047 trial (NCT03470922). In the randomised, multi-centre study, the Opdualag treatment group surpassed double the median progression-free survival of the nivolumab monotherapy group at 10.1 months vs 4.6 months.

The FDA approved the therapy as the first marketed lymphocyte-activation gene 3 (LAG-3)-blocking antibody combination for the treatment of unresectable or metastatic melanoma in March 2022. The European Commission followed this with an approval in September 2022.

Bristol Myers Squibb was previously investigating Opdualag for the treatment of metastatic microsatellite stable colorectal cancer but announced that it would discontinue the clinical program on 15 December. The company terminated the Phase III Relativity-123 trial due to “futility based on a planned analysis conducted by an independent data monitoring committee,” as per a company press release. The review estimated that the trial was unlikely to meet its primary endpoints upon completion

The combination therapy acts by inhibiting the activity of LAG3 and PD1, alleviating the disease condition. LAG3 is expressed on the cell surface of T cells, controlling T cell response activation and growth. BMS reported that the treatment had amassed $162 million in sales revenue in 2023, according to a Q3 update.

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By GlobalData

GlobalData predicts that the combination therapy could reach a peak sales revenue of $2.3bn in 2029.

GlobalData is the parent company of Pharmaceutical Technology.