Patients thrown lifeline after NICE lifts restrictions on game-changing treatment  

Teclistamab is the very first in a new class of drugs, known as a bispecific antibody, approved on the NHS in England and Wales.    

The new drug, which has been hailed as a “miracle” treatment by some patients, has been shown to stop the incurable blood cancer myeloma in its tracks for more than 11 months.   

It has even allowed some people who had never fully responded to treatment up to that point to get their first complete remission.  

Teclistamab was initially approved on the NHS in England and Wales back in July but the approval came with strict restrictions on who could access 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 teclistamab.   

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, hit back at the move to severely limit the number of people able to receive the treatment and made the case for wider access.   

Three months on, NICE has now lifted all previous restrictions.  

Teclistamab 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®).    

Our Senior Policy Officer, Caroline Donoghue said:    

“This is fantastic news and a hard-earned victory for all involved. Teclistamab is the first of a new class of drugs to be approved on the NHS in England and Wales and could be a lifeline for people who are close to running out of treatment options.   

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

“Approvals like this highlight why we continue to fight for treatment, submit evidence on behalf of the myeloma community, attend committee meetings and push for access to pioneering drugs.   

“The initial decision to impose restrictions and keep the drug out of the reach of those who needed it most was deeply unfair. Over the last few weeks we have worked tirelessly to get everyone back around the table, come up with a solution and give people with myeloma a fighting chance to spend more time with their loved ones.  

“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.”  

Teclistamab’s pioneering mechanism of action 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 system. When the bispecific antibody brings them into close contact with the myeloma cells, they are able to destroy these cells.    

According to the latest clinical trial data, patients’ overall response rate was 63%, while the average remission was 11.4 months.   

Kathryn Oddie, a grandmother-of-two from Nottinghamshire, was diagnosed with myeloma at the age of 38 back in 2000.  

Despite receiving 11 rounds of treatment over two decades, she had never been in remission until she was offered teclistamab through the MajesTEC-1 trial in January 2021.   

Three years on, the 62-year-old is still doing well and credits the “miracle” drug for allowing her to live her life.  The retired practice nurse, who was diagnosed after having a nosebleed, said:

“It has been life-changing. It’s a miracle drug, to be honest. I had had 11 lines of therapy – daratumumab had worked for about 18 months to two years – but none of them had put me in remission.   

“At the time, my local hospital said there was nothing else for me but luckily my consultant had worked with Dr Rakesh Popat in the trials unit at UCL a few years back so he wrote to him to see if there was anything that could help me. They rang me to say they had this new drug. I was the first to get teclistamab at UCL.  

“Within six months or so it worked. Now I’m in remission and I can actually get on with my life.”  

Windsor father Bob Munro was diagnosed with myeloma back in 2012. He was just 52.  

By early 2021 he had exhausted all treatment avenues, suffered 10 fractures in two years and taken around 100,000 tablets. His cancer had never once gone into remission.  

Thankfully in 2022, he was able to receive teclistamab through a clinical trial and is now in remission for the first time since his diagnosis.  

The grandfather-of-two said:

“It’s been a minor miracle and I’m so pleased other patients will be able to benefit from this incredible drug.   

“By 2021 I had exhausted all the approved myeloma drugs and I was suffering from catastrophic bone damage – 10 fractures including eight ribs and a collapsed vertebra in the previous two years.  

“I joined the MajesTEC-2 trial and I’m currently two years eight months in remission. It has been my first ever complete remission in 12 years of continuous treatment.    

“Since this complete remission, I’ve been well enough to cycle over 100 miles a week, launch a charity cycling event company and, most importantly, meet a second granddaughter I thought I would never see after my diagnosis in 2012.”   

In hindsight, Bob had had a host of symptoms, including stomach and chest infections he simply couldn’t shake, for months prior to his diagnosis.   

It all came to a head during a skiing trip. He caught pneumonia and was hospitalised.  

An X-ray revealed he had lesions, or holes, all over his back – a tell-tale sign of myeloma.  

“Looking back, I realise there were all sorts of symptoms there. But after I went skiing, I felt I was having a heart attack. It was actually a massive case of pneumonia. They sent me for an X-ray, and they realised my back was covered in lesions.”  

He added:

“The only reason I am still alive is the advancement in research and development of new drugs over the past 10 years. I am living proof.”  

The rollout of teclistamab follows hot on the heels of the approval of elranatamab, another type of bispecific antibody, through the Cancer Drugs Fund (CDF) in July.   

Elranatamab was approved under the same restrictions as teclistamab and Myeloma UK is currently making the case for these to be lifted as well.  

NICE is expected to announce its decision on elranatamab in November.  

What does this decision mean for patients?     

The approval means that teclistamab 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 teclistamab.  

This means patients whose myeloma has become resistant to previous treatments now have access to an innovative treatment which kills the myeloma cells in a new way.     

What about patients in Scotland and Northern Ireland?     

The Scottish Medicines Consortium (SMC) approved teclistamab 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.