Faster, Flexible Cancer Care: Nivolumab Newest Subcutaneous Injection Approval

As of 30 April 2025, a new formulation for Nivolumab has been approved by The Medicines and Healthcare products Regulatory Agency (MHRA) making the treatment process much simpler & faster.

Instead of having a 30–60-minute IV infusion, the new Nivolumab subcutaneous formulation offers a 3-5 minutes injection period, which makes a drastic difference in patients’ compliance. Nivolumab is a type of monoclonal antibody that is used in treatment of various types of common cancer-like lung, bowel, kidney, bladder, esophageal, skin, and head and neck cancers.    

It works by targeting the PD-1 protein on T-cells, preventing cancer cells from deactivating them and enabling the immune system to recognize and eliminate cancer cells.

Also, a recent announcement made by Julian Beach, MHRA Interim Executive Director, stated that the approval of the new subcutaneous nivolumab, will help with improving patient access, reducing clinic time, and ease pressure on NHS services, while still meeting highest safety, quality, and efficacy standards.

Approval was granted based on an open label phase 3 clinical trial that involved advanced or metastatic clear cell renal cell carcinoma patients, testing the new subcutaneous injection of nivolumab with already existing IV version side by side.

Full side effect details will be available in the Patient Information Leaflet and SmPC on the MHRA website within 7 days of approval. The MHRA will continue to closely monitor nivolumab’s safety and effectiveness. Suspected side effects should be discussed with a healthcare professional and reported via the Yellow Card scheme.

Learn more: MHRA authorises cancer treatment variation with an administration time of 3–5 minutes – GOV.UK