Patients hail victory as NICE lifts restrictions on elranatamab

Elranatamab is part of a new class of drugs, known as a bispecific antibody, and has been shown to stop myeloma in its tracks for more than 17 months.  

It was initially approved on the NHS in England and Wales back in June, but the approval came with strict restrictions on who was eligible for the treatment.  

The restrictions meant that those who had previously received the treatments known as IsaPD – a combination of isatuximab, pomalidomide and dexamethasone – or pomalidomide plus dexamethasone (PD), were not eligible for elranatamab.   

This was a huge blow to the many people who had pinned their hopes on the new drug, some of whom faced the prospect of end-of-life care without treatment. 

Myeloma UK, along with patients and clinicians, challenged the decision and fought hard for wider access.  

Three months on, the National Institute for Health and Care Excellence (NICE) has lifted all previous restrictions. 

Elranatamab is now available to anyone who has received at least three rounds of treatment, whose cancer has progressed and who has previously received an immunomodulatory agent such as lenalidomide (Revlimid ®), a proteosome inhibitor like bortezomib (Velcade®) and an anti-CD38 antibody like daratumumab (Darzalex®) or isatuximab (Sarclisa®).   

According to the latest data from the MagnetisMM-3 trial patients’ overall response rate was 61%, while the average remission was 17.2 months.   

Caroline Donoghue, Senior Policy Officer at blood cancer charity Myeloma UK, said: 

“This is brilliant news. Elranatamab is part of a brand-new class of drugs in the UK and will have a huge impact on patients and their families. In fact, we know that it has already changed the lives of many people who were close to running out of treatment options.  

As soon as we heard about the restrictions on access to elranatamab, we challenged the decision. We believed it was deeply unfair to keep this drug out of reach from those who needed it most. We worked with clinicians and made sure that patients were heard and that their needs were put front and centre.

Elranatamab has shown very promising results in clinical trials and allowed some people who have never responded well to treatment to experience their very first complete remission.  

Until we have a cure, it is absolutely vital that all myeloma patients are given as many options to tackle their cancer as possible – no matter where they are on their treatment journey.” 

Elranatamab helps the immune system to recognise and kill cancer cells by binding to both myeloma cells and to T cells. T cells are a type of white blood cell in our immune systems. When the bispecific antibody brings them into close contact with the myeloma cells, they are able to destroy these cells.  

The drug is being rolled out through the Cancer Drugs Fund – a pot of money which provides cancer patients in England with faster access to the most promising new drugs pending full approval from NICE. After a period of three years, NICE will decide whether to make it available permanently on the NHS.     

Jon Missin, from Northamptonshire, is among the hundreds of people who could receive elranatamab now that the restrictions have been lifted.

“It’s fantastic, I’m absolutely delighted with this decision,” said Jon, who was diagnosed with myeloma in 2015 at the age of 41. “I am currently on fourth line treatment on IsaPD, but soon to finish it as my disease levels have been creeping up in recent months.

“For many patients, there was little available beyond their fourth line treatment, but bispecifics are a game-changer and, now elranatamab has been approved without restrictions, it provides much hope.“

The 51-year-old added: “A huge thank you to Myeloma UK for all their work behind the scenes in getting this across the line. It has certainly opened my eyes as to the amount of work they do to the benefit of the myeloma community. They should take much credit for this.”

The rollout of elranatamab follows the approval of teclistamab, another type of bispecific antibody, earlier this month.  

What does this decision mean for patients?     

The approval means that elranatamab is available to eligible myeloma patients as a potential treatment option in England and Wales.    

Patients at third relapse (fourth line) and beyond who have previously been treated with an immunomodulatory drug, a proteosome inhibitor and an anti-CD38 monoclonal antibody can now receive elranatamab.  

What about patients in Scotland and Northern Ireland?     

The Scottish Medicines Consortium (SMC) approved elranatamab for use on the NHS in Scotland in September.        

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.