Johnson & Johnson (J&J) has announced that the National Institute for Health and Care Excellence (NICE) has published Final Draft Guidance recommending Darzalex (daratumumab) plus bortezomib, lenalidomide and dexamethasone (D-VRd) followed by daratumumab plus lenalidomide maintenance treatment for previously untreated multiple myeloma in adults when an autologous stem cell transplant (ASCT) is suitable.
As a result, eligible patients can soon receive D-VRd on the NHS in England and Wales as an induction therapy in advance of their ASCT, followed by D‑VRd consolidation and daratumumab plus lenalidomide maintenance after ASCT.
Around 33,000 people in the UK are currently living with multiple myeloma, an incurable type of blood cancer. As a relapsing-remitting condition, myeloma becomes more resistant to treatment over time. With every relapse, each line of treatment is less effective than the last, making it vital that patients receive the most effective therapy at first-line when they are most likely to benefit. The disease carries a large psychological impact because of the constant possibility of relapse.
NICE’s guidance also states that D-VRd can be used for people who have received daratumumab plus bortezomib, thalidomide and dexamethasone induction and consolidation treatment and who have not yet started maintenance treatment, expanding the eligible pool of patents.
Importantly, NICE has also recommended an innovative minimal residual disease (MRD)-guided approach to treatment. During maintenance, patients will undergo MRD testing using bone marrow samples, and daratumumab may be stopped after at least 24 months of maintenance treatment if MRD has remained negative for at least 12 months, while lenalidomide maintenance may continue. NICE recognised that using MRD status to guide treatment decisions represents a ‘step change’ in the management of myeloma, offering eligible patients the potential to reduce treatment burden and hospital visits while maintaining disease control.
“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,” said Amanda Cunnington, UK Senior Director of Patient Access, Johnson & Johnson. “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.”