NICE has issued Final Draft Guidance recommending daratumumab plus bortezomib, lenalidomide and dexamethasone for previously untreated multiple myeloma in adults suitable for an autologous stem cell transplant. Johnson & Johnson said the decision means eligible patients in England and Wales will soon be able to receive the quadruplet as first‑line induction therapy before transplant, followed by consolidation and daratumumab plus lenalidomide maintenance.
The guidance is based on phase 3 PERSEUS data showing a 58% reduction in risk of disease progression or death for the daratumumab‑based regimen compared with standard VRd induction and consolidation followed by lenalidomide maintenance.
NICE also endorsed an MRD‑guided approach, allowing daratumumab to be stopped after at least 24 months of maintenance if MRD remains negative for at least 12 months.
Scott Purdon, Head of Patient Advocacy at Myeloma UK, said: “This is fantastic news and shows that personalised treatment is absolutely the future of myeloma care.” He added: “D‑VRd has been shown to deliver long and deep responses for myeloma.”
Dr Ceri Bygrave, Consultant Haematologist and UK Myeloma Society Advocacy Lead, said: “The substitution of lenalidomide for thalidomide will have benefit in terms of less frequent incidence of neurotoxicity and improved depth response.” He added: “Patients, carers and clinicians working in the field of myeloma have been anxiously awaiting this decision as we work towards our shared goal of finding a long‑term cure for myeloma.”
Amanda Cunnington, UK Senior Director of Patient Access at Johnson & Johnson, said: “We are delighted that people with myeloma who are eligible for a stem cell transplant will now have access to daratumumab across the entire front‑line treatment sequence – including maintenance, where lenalidomide monotherapy remains the current standard of care.” She added: “It is essential that people with multiple myeloma have as many treatment options available to them as early as possible, when they are fitter and most likely to benefit.”
PERSEUS showed a hazard ratio of 0.42 for progression‑free survival at 47.5 months. Safety findings were consistent with known profiles, with neutropenia and thrombocytopenia the most common grade 3 or 4 adverse events.
