Medicines Healthcare Products Regulatory Agency
This is a cancer medicine used to treat advanced melanoma, a type of skin cancer that can spread to other areas of the body. The main risk factor for melanoma is exposure to ultraviolet light, which comes from the sun and is used in sunbeds. Around 17,000cases ofmelanomaare diagnosed every yearin the UK, although notall of those are advanced melanoma.
Opdualag has been 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, Agncia Nacional de Vigilncia Sanitria in Brazil and Israels Ministry of Health, coordinated by the US Food and Drug Administration. This programme reviews and approves promising cancer drugs, helping patients to access treatments more quickly.
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 treatment is administered via a drip over 30 minutes every four weeks in a hospital under the supervision of a doctor experienced in cancer treatment.It is continued for as long as clinical benefit is observed by the doctor, or until side effects become too severe.
How it works
The active ingredients in Opdualag, nivolumab and relatlimab, are monoclonal antibodies. These are a type of protein designed to recognise and attach to a specific target substance in the body, helping a patients immune system fight cancer.
Nivolumab attaches to a target protein called PD 1. Relatlimab attaches to a target protein called LAG-3. PD 1 and LAG-3 can switch off the activity of T cells (a type of white blood cell that forms part of the immune system, the bodys natural defences).
By attaching to the two proteins, nivolumab and relatlimab block their actions and prevent them from switching off the T cells. This helps increase the T cell activity against the melanoma cancer cells.
Evidence base
The authorisation of Opdualag is supported by evidence from a phase 2/3 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.
Side effects
The most common side effects of the medicine(which may affect more than 1 in 10 people)aretiredness, 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,anddecreased number of red and white blood cells.
As with any medicine, the MHRA will keep the safety and effectiveness of Opdualag under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors
- The new marketing authorisation was granted on 27 December 2023 to Bristol-Myers Squibb Pharma EEIG.
- More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
- The aim of Project Orbis is to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies. For more information, see:Project Orbis - GOV.UK (www.gov.uk)
- This was a randomised, double-blind trial, where neither the participants nor the staff on the trial were aware of what each participant was taking. For more information about the study, see the Summary of Product Characteristics.
- For more information on melanoma see: Melanoma - NHS (www.nhs.uk)
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call