NICE has issued final draft guidance recommending daratumumab with bortezomib, lenalidomide and dexamethasone (D‑VRd) for adults with untreated multiple myeloma who are unsuitable for an autologous stem cell transplant.
The decision means eligible patients in England and Wales will gain access to the UK’s only licensed subcutaneous CD38‑directed antibody quadruplet for first‑line use.
Multiple myeloma affects around 33,000 people in the UK and remains incurable. As the disease becomes harder to treat with each relapse, clinicians emphasise the importance of effective first‑line therapy, particularly for the two‑thirds of newly diagnosed patients who cannot receive a transplant.
Caroline Donoghue, Access Manager at Myeloma UK, said: “This is fantastic news and a hard-earned victory for patients who felt let down by NICE’s initial decision not to approve D-VRd. We have been working very hard to get NICE to reconsider and we’re delighted they’ve agreed to roll it out on the NHS.
“We know how devastating being diagnosed with myeloma is and newly diagnosed patients deserve to have as many options available to them right from the off as it may mean less time spent in hospital for patients and their families.
She added: “We can’t emphasise enough what this means for their quality of life. Until we have a cure, it is absolutely vital that people with myeloma get the treatment they need as soon as they’re diagnosed.”
Professor Supratik Basu, Haematology Consultant at The Royal Wolverhampton NHS Trust and University, said: “Bortezomib is a well-known therapy, and its addition to the daratumumab plus lenalidomide and dexamethasone triplet regimen is a great example of how a small change can have a big impact.
“Having proudly been an investigator in the CEPHEUS trial in Wolverhampton, I’ve seen first-hand just how important it is that transplant-ineligible myeloma patients, who represent the majority of the myeloma population, have as many treatment options available to them as possible in the first-line setting.”
NICE’s recommendation is based on the phase 3 CEPHEUS trial, which showed an overall minimal residual disease‑negativity rate of 60.9% with D‑VRd compared with 39.4% for the triplet regimen at a median follow‑up of 58.7 months.
Nina Pinwill, UK Director of Strategic Access, Pricing and Operations at Johnson & Johnson, said: “We are delighted that D-VRd is now available on the NHS to eligible patients with multiple myeloma who are not suitable to receive a stem cell transplant. J&J’s long-standing heritage in myeloma means we know just how important it is for patients to have as many first-line treatment options available to them as possible.
“I would like to say a massive thank you to everyone involved in the appraisal process who helped to bring about this positive outcome, which I hope comes as welcome news to the patient community and their loved ones.”
