HQ Team
May 1, 2025: Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new under-the-skin injection version of the cancer therapy, nivolumab (Opdivo), offering a quicker administration option for eligible patients than the currently available drip treatment.
The subcutaneous formulation of nivolumab can be given as a three to five injection instead of the 30 or 60-minute intravenous (IV) infusion, according to an MHRA statement.
Several common cancers can be treated by nivolumab, including lung, bowel, kidney, bladder, oesophageal, skin, and head and neck. A subcutaneous administration delivers treatment under the skin and is an alternative to intravenous infusion.
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 find and kill cancer cells.
Depending on the cancer type, patients might have nivolumab on its own or in combination with other anti-cancer drugs. Opdivo, manufactured by Bristol Myers Squibb, is an immunotherapy that works differently from chemotherapy. Immunotherapies are treatments that work with the body’s immune system to fight disease.
Adverse reactions
When combined, Opdivo and Yervoy work in different but complementary ways to help your immune system fight your cancer in a way that is greater than when either medication is used alone.
As the combination works with the immune system, it can cause the body’s immune system to attack normal organs and tissues in any area of the body and affect how they work.
These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or after the treatment has ended. Patients may have more than one of these problems at the same time. Some of these problems may happen more often when Opdivo is used in combination with another therapy.
Nivolumab, branded as Opdivo, received FDA approval in 2014. Depending on the indication, it can be given as a single agent or in combination with ipilimumab (anti-CTL4 immune checkpoint inhibitor).
‘Safety a priority’
“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,” said Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access.
“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,” he said.
MHRA’s approval was based on evidence from a randomised, open-label end-stage 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.
Range of cancers
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. “The MHRA will keep the safety and effectiveness of nivolumab under close review,” according to the statement.
The approval for Bristol Myers Squibb covers a broad range of cancers, including kidney, skin (melanoma), lung, head and neck, bladder, bowel (colorectal), liver, stomach, and cancers of the oesophagus.
The 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 body is an executive agency of the Department of Health and Social Care.
