NICE recommends daratumumab quadruplet for newly diagnosed multiple myeloma
pharmafile | October 8, 2026 | News story | |Â Â NICE, Oncology, drug recommendation, drug regulationÂ
NICE has published final draft guidance recommending daratumumab with bortezomib, lenalidomide and dexamethasone (D-VRd) for previously untreated adults with multiple myeloma who are eligible for an autologous stem cell transplant (ASCT).
Under the recommendation, patients can receive D-VRd as induction and consolidation treatment around their transplant, followed by daratumumab plus lenalidomide maintenance. The guidance also allows D-VRd for patients who have already received daratumumab, bortezomib, thalidomide and dexamethasone and have not yet started maintenance treatment.
The recommendation is based on the phase 3 PERSEUS trial, in which D-VRd reduced the risk of disease progression or death by 58% compared with bortezomib, lenalidomide and dexamethasone followed by lenalidomide maintenance (hazard ratio 0.42, 95% CI 0.30–0.59; P<0.001) after a median follow-up of 47.5 months.
At 48 months, an estimated 84.3% of patients receiving D-VRd remained progression-free, compared with 67.7% in the comparator group. MRD negativity was also higher with D-VRd, at 75.2% versus 47.5%, while 64.8% achieved sustained MRD negativity for at least 12 months compared with 29.7%.
NICE has also recommended an MRD-guided approach during maintenance. Daratumumab may be stopped after at least 24 months if a patient has remained MRD-negative for at least 12 months, while lenalidomide maintenance can continue. NICE said the approach could reduce treatment burden and hospital visits while maintaining disease control.
The safety profile was consistent with the known profiles of the treatments. Grade 3 or 4 neutropenia occurred in 62.1% of patients receiving D-VRd and 51% of those receiving VRd, while treatment discontinuation because of adverse events occurred in 8.8% and 21.3%, respectively.
Around 33,000 people in the UK are living with multiple myeloma, according to the release. The disease is incurable and typically follows a relapsing-remitting course, making treatment strategies that extend remission particularly important.
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