The Medicines and Healthcare products Regulatory Agency (MHRA) has today (30 April 2025) approved a new under-the-skin injection version of the cancer therapy, nivolumab (Opdivo), offering a quicker administration option for eligible patients.
The subcutaneous formulation of nivolumab can be given as a 3–5-minute injection instead of the 30- or 60-minute intravenous (IV) infusion. Several common cancers can be treated by nivolumab, including lung, bowel, kidney, bladder, oesophageal, skin, and head and neck cancers.
Nivolumab is a monoclonal antibody that works by binding to a protein called PD-1 (programmed death-1) on a type of immune cell called T-cells. This blocks cancer cells from switching off T-cells, allowing the immune system to detect and destroy cancer cells.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:
“Patient safety is our top priority, which is why I am pleased to confirm the national approval of the new under-the-skin injection version of nivolumab.
“This approval marks an important step forward in improving treatment access and reducing the time patients spend in clinics. It has the potential to ease pressures on NHS services, while also giving patients flexibility in their care.
“We’re assured that the appropriate regulatory standards of safety, quality, and efficacy for the approval of this new formulation have been met. As with all products, we will keep its safety under close review.”
Today’s national approval is based on evidence from a randomised, open-label Phase 3 clinical trial, involving patients with advanced or metastatic clear cell renal cell carcinoma. Participants received either the new injection version of nivolumab or the established IV version.
Results showed that the injection produced comparable levels of drug in the body (pharmacokinetics) and a similar safety and tumour response profile to the IV formulation.
A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), available on the MHRA website within 7 days of approval.
As with any medicine, the MHRA will keep the safety and effectiveness of nivolumab under close review.
Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse and report it directly to the MHRA 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
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The approval was granted on 30 April 2025 to Bristol Myers Squibb.
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This product was submitted and approved via national procedure.
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Subcutaneous administration delivers treatment under the skin and is an alternative to intravenous infusion.
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A randomised, open-label Phase 3 clinical trial is a large, late-stage study where participants are randomly assigned to different treatment groups, both doctors and patients know which treatment is being given (open-label), and the goal is to confirm the treatment’s effectiveness and safety before potential regulatory approval.
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The approval covers a broad range of cancers, including kidney, skin (melanoma), lung, head and neck, bladder, bowel (colorectal), liver, stomach, and cancers of the oesophagus.
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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.
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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.
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The MHRA is an executive agency of the Department of Health and Social Care.
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