Nivolumab-relatlimab combination for melanoma approved in UK

Monoclonal antibody

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bristol Myers Squibb’s advanced melanoma drug Opdualag (nivolumab-relatlimab) for patients from the age of 12.

Opdualag was authorised through Project Orbis, a global partnership 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).

This programme reviews and approves promising cancer drugs, helping patients to access treatments more quickly.

Opdualag has been approved in the US for patients 12 years or older with unresectable or metastatic melanoma since March 2022.

Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said: “Project Orbis aims to open access to safe and effective new cancer drugs for patients that need them. As with all products, we will keep the safety of Opdualag under close review.”

The active ingredients in Opdualag, nivolumab and relatlimab, are monoclonal antibodies. Nivolumab attaches to a target protein called PD1, while relatlimab attaches to a target protein called LAG-3. PD1 and LAG-3 can switch off the activity of T cells.

The authorisation of Opdualag is supported by evidence from a Phase II/III randomised, double-blind clinical trial involving 714 patients with previously untreated advanced melanoma. The patients were given either 480mg nivolumab with 160mg of relatlimab, or 480mg of nivolumab alone, every four weeks.

This study showed that the combined treatment was more effective at slowing the progression of the disease over those given nivolumab alone.

Patients who were given the combined treatment lived for an average of 10.1 months without their disease getting worse. This compares with an average of 4.6 months for patients having treatment with nivolumab alone.

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