NICE approves BVD at second line on the NHS

Maddie Dichiu
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A cutting-edge treatment that could give people at second line remissions of more than three years has been approved on the NHS in England and Wales.

BVD combines belantamab mafodotin (Blenrep®), bortezomib (Velcade®) and dexamethasone. It is aimed at patients who have received one previous line of treatment only, which included lenalidomide (Revlimid®), and whose myeloma is refractory to lenalidomide or the patient cannot tolerate lenalidomide.  

The triplet has been shown to stop myeloma in its tracks for more than 36 months on average. DREAMM-7 phase 3 trial results demonstrated that the belantamab mafodotin combination nearly tripled median progression-free survival versus standard of care combination in patients with relapsed and/or refractory myeloma. 

The positive decision by NICE makes the UK the first place worldwide where BVD has been made available.

Shelagh McKinlay, Director of Research and Advocacy at Myeloma UK, said:

“This is fantastic news. We have been working very hard for the last year to get this treatment approved and we know it will transform the lives of thousands of people with myeloma. 

“Approvals like this highlight why we continue to fight for access to pioneering drugs, work alongside decision-makers, attend committee meetings and submit lived-experience evidence on behalf of the myeloma community. 

“While this is good news for most, NICE’s decision to limit access to BVD is hugely frustrating and will no doubt cause unnecessary uncertainty and distress to those for whom this new drug could have been a lifeline. 

“Every day counts when you’re living with myeloma because only one thing is certain: myeloma will always come back. This means patients need the best, most effective treatments now. And we will keep pushing every step of the way for BVD to be made available across the rest of the UK and to everyone who will benefit from it – no matter where they are on their treatment journey. 

“Until we have a cure, it is absolutely vital that all patients are given as many options to control their disease as possible.” 

The approval is a significant milestone and the result of three years’ work which started in 2022, as part of NICE’s review of the use of belantamab mafodotin as a monotherapy at fourth line. Myeloma UK provided vital patient insights and experience of receiving belantamab mafodotin monotherapy.

Following MHRA and EMA recommendation to terminate the monotherapy licence, GSK committed to the DREAMM-7 and 8 clinical programme to demonstrate safety and efficacy of belantamab mafodotin in combination at second line. This resulted in a new MHRA licence approval in April 2025, for use in patients who have had one prior line of treatment, and NICE’s positive decision this month. 

Myeloma UK continues to work to seek access to belantamab mafodotin combinations for everyone who may benefit. We highlighted the need for broader access in the NICE committee meetings, and we will continue to work with GSK, NICE and NHSE to seek access in line with the MHRA licence. 

Belantamab mafodotin is an antibody-drug conjugate, which specifically targets a protein on the surface of myeloma cells called BCMA. This helps deliver chemotherapy straight to the myeloma cells and flags them for the patients’ immune system to kill.  

Paul Silvester, a father-of-three from Sheffield, is one of the people who has already benefitted from BVD.  

Paul was enrolled in a clinical trial for BVD last February. Within weeks, the former headteacher went into remission. 

“I feel like this treatment has brought the party balloons back in the house,” said the 60-year-old. “It’s been amazing, really. Within the first two or three weeks, after the first dose, my light chains went from 1,300 down to six, which is counted as being in remission. My consultant said it’s probably the biggest decline they’ve witnessed.  

“It gives me quite a lot of confidence in the drugs and it makes me more optimistic about the future. I’ve been feeling well in myself and I’m still quite active – that’s what’s important in terms of your quality of life.” 

He added: “One of my daughters is doing biomedical engineering at Imperial and she graduates in October. That’s a goal for me, that’s what I’m looking at – to be there.”

NICE is yet to make a decision on another treatment known as BPD – a combination of belantamab mafodotin, pomalidomide (Imnovid®) and dexamethasone – for use at second line. We anticipate an update from NICE in the next month with the prospect of a second NICE committee meeting to review the cost-effectiveness of this combination at second line. 

What is BVD? 

BVD is a combination of belantamab mafadotin (Blenrep®), bortezomib (Velcade®) and dexamethasone. Belantamab mafodotin is an antibody-drug conjugate, which specifically targets a protein on the surface of myeloma cells called BCMA. This helps deliver chemotherapy straight to the myeloma cells and flags them for the patients’ immune system to kill.  

Who can access BVD? 

The treatment will be available to myeloma patients who have had at least one previous line of treatment only (also known as second line) and are either refractory or intolerant to lenalidomide. 

When will BVD be available on the NHS? 

A draft positive recommendation from NICE means clinicians can start prescribing the treatment to eligible patients. However, it may take some time for the treatment to become available, depending on the treatment itself and the capacity of hospitals to deliver it. 

The treatment should be made available to patients through the NHS within 90 days of the final decision being published. 

What about patients living in Scotland and Northern Ireland?

In Scotland, the Scottish Medicines Consortium (SMC) makes decisions about which treatments to fund through the NHS and BVD is currently being reviewed by the SMC. 

In Northern Ireland, the Department for Health makes decisions on which treatments to fund through the NHS. It can follow final guidance issued by either NICE or the SMC but usually follows the guidance issued by NICE. Treatments are made available following final guidance by NICE. This approval came with draft guidance.

We are working with our clinical community and policymakers in Northern Ireland to advocate for access to BVD following NICE draft guidance to ensure equal access as with English and Welsh patients. 

What about eye-related side effects?  

Eye-related (ocular) side effects are a known, common complication associated with belantamab mafodotin treatment, however this led to low treatment discontinuation (≤9%) in both belantamab mafodotin combination trials (DREAMM-7 and DREAMM-8). The ocular side effects have been found to be resolvable through management in most cases – with extended time between infusions and dose reductions found to be effective for management of the side effect whilst maintaining efficacy of myeloma treatment.  

GSK is working with NHSE to support management of eye-related toxicity through a patient-support programme.

Is belantamab mafadotin still available on a clinical trial?

Yes. Belantamab mafadotin is currently available as a monotherapy and in combination with other myeloma treatments on clinical trials.  

Our Myeloma Trial Finder lists those trials that are currently recruiting in the UK. The ProMMise-D trial offers access to BVD whilst exploring alternative monitoring for ocular toxicities and is recruiting at hospitals across the UK. ProMMise-D is an arm of the ProMMise trial, which was developed through the Concept and Access Research Programme (CARP), an initiative funded by Myeloma UK which aims to support the development of innovative myeloma clinical trials in the UK. Find out more here. 

Useful resources 

Information for patients 

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