Johnson & Johnson’s (J&J’s) blockbuster cancer therapy, Darzalex (daratumumab), is set to secure a wider recommendation from the UK’s health watchdog in multiple myeloma, marking a change of heart from the agency, while expanding the drug’s role in treatment across the National Health Service (NHS).
As per a final draft guidance from the UK’s National Institute for Health and Care Excellence (NICE), a quadruplet regimen incorporating anti-CD38 therapy, Darzalex plus bortezomib, lenalidomide and dexamethasone, known as D-VRd, will now likely become available to English and Welsh patients with frontline, stem cell transplant-ineligible multiple myeloma.
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NICE’s recommendation could expand Darzalex’s current role within the NHS’s multiple myeloma treatment arsenal, in which it is used alongside bortezomib and dexamethasone (DVd) in patients who have received at least one prior line of therapy. While the medicine is currently available in combination with lenalidomide and dexamethasone as a front-line treatment option for patients with transplant-ineligible disease, this marks the first time the UK health watchdog has given a Darzalex-containing quadruplet regimen the go-ahead in this population.
D-VRd’s NICE recommendation was based on the results of the Phase III CEPHEUS study (NCT03652064), which revealed that 60.9% of patients achieved overall minimal residual disease (MRD) negativity at a median follow-up of 58.7 months compared with 39.4% receiving standard of care (SoC) bortezomib, lenalidomide and dexamethasone (VRd), meeting the trial’s primary endpoint.
NICE’s Darzalex decision turnaround
NICE’s decision to greenlight D-VRd in the frontline, transplant-ineligible multiple myeloma population marks a U-turn from the agency’s previous decision on the regimen, as it declined to recommend D-VRd for first-line use in patients with both transplant-eligible and ineligible disease back in January 2026. As it stands, the health watchdog still doesn’t recommend the quadruplet regimen for use in transplant-eligible patients – primarily due to concerns around its cost-effectiveness.
D-VRd could now join Sanofi’s fellow anti-CD38 antibody, Sarclisa (isatuximab), on the health watchdog’s ‘nice’ list, as the agency previously opted to recommend the drug in combination with bortezomib, lenalidomide, and dexamethasone (Isa-VRd) for NHS use in frontline, transplant-ineligible multiple myeloma back in September 2025. If approved for use by the health service, D-VRd could offer patients a dosing advantage over Isa-VRd, as Darzalex is administered via subcutaneous injection, rather than intravenously like Sarclisa.
According to Caroline Donoghue, access manager at Myeloma UK, NICE’s D-VRd recommendation is “fantastic news and a hard-earned victory for patients”.
“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. We can’t emphasise enough what this means for their quality of life,” she added.
Darzalex’s key patents begin to expire in 2026, meaning J&J could potentially face biosimilar competition for the drug soon.
