IsaVRD approved for transplant-ineligible patients in England and Wales

Published: Friday, 5 Sep 2025

The National Institute for Health and Care Excellence (NICE) have approved the very first quadruplet treatment for newly diagnosed myeloma patients who are ineligible for a stem cell transplant in England and Wales.

The quadruplet combines isatuximab (Sarclisa^®), bortezomib (Velcade^®), lenalidomide (Revlimid^®) and dexamethasone (IsaVRD) and around 3,300 patients could benefit from the treatment each year.

The treatment was initially not recommended by the NICE over uncertainty around cost-effectiveness.

Myeloma UK submitted more data and evidence to NICE’s appraisal committee and, along with clinicians and the pharmaceutical company behind the treatment, successfully made the case for IsaVRD to be rolled out on the NHS.

Scott Purdon, Head of Patient Advocacy at Myeloma UK, said:

“This is the result of months of hard work, and we couldn’t be happier to see IsaVRD finally approved on the NHS.
“As the first quadruplet treatment for transplant-ineligible patients, IsaVRD will change the lives of thousands of people with myeloma. The four drug combination not only targets myeloma cells in four different ways but also offers more flexibility to manage side effects.
“Our work is far from over. IsaVRD is currently being assessed by the Scottish Medicines Consortium, and we’re determined to get it across the line in Scotland.
“Until we have a cure, it is vital that all patients are given as many options to control their myeloma as possible, no matter where they live or where they are on their treatment journey.” 

The decision to recommend IsaVRD is based on the data from the phase 3 IMROZ clinical trial. In the trial, IsaVRD delivered some of the deepest responses reported for this patient population with 58% of the people receiving IsaVRD reaching minimal residual disease negativity and 46% having sustained minimal residual disease negativity for at least 12 months.

The trial also showed it has the potential to lengthen progression-free survival with 63% of the patients on IsaVRD continuing to be progression-free after five years.

Q&A

What does this decision mean for people with myeloma?

The approval means eligible myeloma patients in England and Wales can now access IsaVRD. Newly-diagnosed patients who can’t have high-dose therapy and stem cell transplantation can now receive IsaVRD. 

This means that people who can’t have a stem cell transplant now have access to a quadruplet for first time. It also means more patients could potentially have no detectable signs of myeloma in their blood and bone marrow following treatment, for longer.

What is IsaVRD?

IsaVRD is a combination of four drugs: isatuximab, bortezomib, lenalidomide and dexamethasone.

Isatuximab belongs to a group of drugs known as monoclonal antibodies. It works by harnessing the body’s immune system. It is a synthetic antibody designed to target myeloma cells by detecting a protein commonly found on the surface of myeloma cells called CD38. When it finds and attaches to CD38, it makes the myeloma cell more visible to the immune system. It helps the patient’s immune system locate and kill myeloma cells.

Isatuximab is currently used in combination with pomalidomide (Imnovid®) and dexamethasone (IsaPD) to treat myeloma patients who have had three previous lines of treatment, including lenalidomide and a proteasome inhibitor, and whose myeloma has progressed on their last treatment.

What about patients in Scotland and Northern Ireland?

In Scotland, the Scottish Medicines Consortium (SMC) makes decisions about which treatments to fund through the NHS. The SMC has started an appraisal for IsaVRD. We hope it will be approved for use in Scotland later this year.

In Northern Ireland, the Department for Health makes decisions on which treatments to fund through the NHS. It can follow guidance issued by either NICE or the SMC but usually follows the guidance issued by NICE.

When will IsaVRD be available on the NHS? 

A positive recommendation from NICE means clinicians can start prescribing the treatment to eligible patients. It may take some time for the treatment to become available. This depends on the treatment and hospitals’ capacity to deliver it.  

However, the treatment should be made available to patients through the NHS within 90 days of the publication of the final decision. 