, 2025-05-01 14:54:00
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a subcutaneous injectable version of the cancer drug nivolumab (Opdivo, Bristol Myers Squibb).
NHS England said it would be the first health service in Europe to offer this therapy.
The injection takes just 3-5 min to administer, compared with 30-60 min for the intravenous (IV) infusion.
Patients will still attend hospital every 2-4 weeks but will spend significantly less time there.
Used for Multiple Cancers
The subcutaneous formulation can treat 15 types of cancer, including:
- Kidney
- Melanoma
- Lung
- Head and neck
- Bladder
- Colorectal
- Liver
- Stomach
- Oesophageal
Julian Beach, MHRA interim executive director of healthcare quality and access, said the new option may improve treatment access and reduce pressure on NHS services.
It is also expected to enhance patient experience by offering more flexibility in care.
Study Shows Comparable Results
The MHRA approval was based on evidence from the CheckMate 67T study .
This randomised, open-label phase 3 clinical trial compared subcutaneous and IV nivolumab in patients with previously treated advanced or metastatic clear cell renal cell carcinoma.
The results showed comparable efficacy between the two formulations, with objective response rates of 24.2% vs 18.2% for subcutaneous and intravenous nivolumab, respectively.
Safety profiles were consistent between the two arms, with patients preferring subcutaneous over intravenous treatment.
Nivolumab is a monoclonal antibody that works by binding to a protein called PD-1 on T-cells. This blocks cancer cells from switching off T-cells, allowing the immune system to detect and destroy cancer cells.
Nivolumab is increasingly being recommended as a cancer treatment. In April, the National Institute for Health and Care Excellence recommended the drug for some patients with advanced colorectal cancer.
NHS to Begin Treatment This Month
NHS England said the injection will be available to patients later this month, pending the arrival of supplies.
An estimated 1200 people in England are expected to benefit each month.
Two in five patients who currently receive IV nivolumab should be eligible, and most new patients are likely to start on the injectable version.
Clinician Time and Capacity Gains
Use of the injectable version could save around 1000 hours of treatment time every month for patients and clinicians, according to NHS England. This equates to more than one full year of treatment time annually across patients, clinicians, nurses, and pharmacy teams.
“Being able to offer it as an injection in minutes means we can make the process far more convenient,” said Professor Peter Johnson, NHS England national clinical director for cancer in a statement. “It will free up thousands of valuable clinicians’ time every year, allowing teams to treat even more patients and helping hospital capacity.”
The new formulation comes at no extra cost to the NHS. A price was secured through a negotiated agreement between NHS England and Bristol Myers Squibb.
Dr Rob Hicks is a retired NHS doctor. A well-known TV and radio broadcaster, he has written several books and has regularly contributed to national newspapers, magazines, and online. He is based in the UK.
