MHRA approves Bristol Myers Squibb’s Opdualag for advanced melanoma treatment

The American biopharmaceutical company receives marketing authorisation for the drug through Project Orbis

 The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bristol Myers Squibb’s Opdualag (nivolumab and relatlimab) for treatment of advanced melanoma for patients aged 12 and above.

Melanoma is a type of skin cancer that is mainly associated with exposure to ultraviolet light from the sun or sunbeds. Every year, an estimated 17,000 cases of melanoma are diagnosed in the UK, but not all of patients have advanced melanoma. This type of cancer can spread to other areas of the body.

The American biopharmaceutical company received the MHRA marketing authorisation for the drug as part of Project Orbis, an international partnership designed to help cancer patients access to promising cancer treatments.

It is an initiative of the US FDA Oncology Center of Excellence (OCE), and global partners include 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.

Opdualag therapy was the first approved the FDA for the treatment of unresectable or metastatic melanoma in March 2022, followed by the European Commission’s approval in September 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.”

Know more about the new cancer drug

Opdualag contains active ingredients, nivolumab and relatlimab, which are monoclonal antibodies designed to recognise and attach to specific target proteins called PD 1 and LAG-3 respectively in the body.

These two proteins can switch off the activity of T cells, a type of white blood cell that forms part of the immune system.

By attaching to them, nivolumab and relatlimab can block their actions and prevent them from switching off the T cells, which help a patient’s immune system to fight melanoma cancer cells.

The MHRA’s approval of Opdualag is supported by evidence from a phase 2/3 randomised, double-blind clinical trial involving 714 patients with previously untreated advanced melanoma.

Patients who received the Opdualag treatment lived for an average of 10.1 months without their disease getting worse, compared to the nivolumab monotherapy group who had an average of 4.6 months of progression-free survival.

The medicine is administered to the patient via a drip over 30 minutes every four weeks in a hospital under the supervision of an experienced oncologist, and the treatment is continued until its clinical benefit is observed, or until it leads to severe side effects.

According to the regulatory authority, the most common side effects of the medicine include tiredness, pain in muscles, bones and joints, skin rash (sometimes with blisters) and itching, decreased appetite, headache, diarrhoea, constipation, nausea, vomiting, stomach pain, fever, cough, difficulty breathing, underactive thyroid gland, skin colour change in patches (vitiligo), urinary tract infection, and decreased number of red and white blood cells.