First personalised myeloma treatment DVRD approved on the NHS
The National Institute for Health and Care Excellence (NICE) has approved DVRD (daratumumab (Darzalex®), bortezomib (Velcade®), lenalidomide (Revlimid®) and dexamethasone) for the treatment of newly diagnosed patients in England and Wales who are eligible for a stem cell transplant.
It is the first tailored treatment for newly-diagnosed patients due to the unique amendments to DVRD’s maintenance phase based on the patient’s minimal residual disease (MRD) status.
People who have been on maintenance for 24 months and have had sustained MRD negativity for at least 12 months can come off daratumumab. This can help reduce the burden of treatment, including side effects and hospital visits.
It also allows the much-anticipated switch from thalidomide to lenalidomide during induction and gives stem cell transplant (SCT)-eligible patients access to doublet maintenance of daratumumab and lenalidomide for the first time.
Around 1,900 people could benefit from the new treatment each year.
This approval of DVRD marks the first time NICE has considered every aspect of the treatment sequence, from induction to maintenance, for transplant-eligible patients.
The final guidance not only approves the full sequence for use on the NHS but also approves the use of maintenance with daratumumab and lenalidomide for any patient who has already had induction and consolidation with DVTD but has not yet started maintenance treatment with lenalidomide alone.
The decision to approve DVRD was largely based on the phase 3 PERSEUS trial which compared DVRD to VRD (bortezomib, lenalidomide and dexamethasone). In the trial, the estimated percentage of patients with progression-free survival at 48 months was 84.3% in the DVRD group and 67.7% in the VRD group.
The approval of DVRD has taken longer than usual, after the treatment was not recommended twice by the drug-approval body.
Myeloma UK made a strong case for NICE to reconsider, submitted further evidence and patient testimonies and, after 18 months, finally got the treatment over the line.
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. DVRD has been shown to deliver some of the longest, deepest responses we’ve seen to date for myeloma.
While we know that NICE has worked hard and we’re pleased it has approved DVRD, it shouldn’t have taken us 18 months to get here. There’s no skirting around the fact that thousands of patients missed out on this effective drug combination because of a slow and complex approval system that simply was not designed to quickly assess innovative treatments like DVRD. People with myeloma deserve faster and fairer access to the treatments they so desperately need. This is why we’ve launched the Closer to a Cure report, which calls for urgent change and sets out how we can make it happen if we act together now.
Until we have a cure, it is absolutely vital that people with myeloma get the best chance to keep their cancer at bay and live well for as long as possible.”
Q&A
What is DVRD?
DVRD is a combination treatment used to treat myeloma. It contains four drugs: daratumumab, bortezomib, lenalidomide and dexamethasone.
All these are already being used to treat myeloma but in different combinations. For example, the current induction treatment given to newly-diagnosed myeloma patients who can have a stem cell transplant is DVTD, a combination of daratumumab, bortezomib, thalidomide and dexamethasone.
There are now two approved uses of DVRD. One as a treatment for newly-diagnosed patients who can’t have a stem cell transplant (ineligible) and the other for newly-diagnosed patients who can have a stem cell transplant (eligible).
For transplant-ineligible patients, DVRD is given in two phases: induction and maintenance. In the induction phase, patients get all four drugs. In the maintenance phase, patients come off bortezomib and continue with DRD.
For transplant-eligible patients, DVRD is given in three phases: induction, consolidation and maintenance. In the induction and consolidation phases, patients get all four drugs. In the maintenance phase, patients come off bortezomib and dexamethasone and continue taking daratumumab and lenalidomide as maintenance. Patients who have been on maintenance for at least 24 months and have had no detectable myeloma cells in the blood or bone marrow for at least 12 months, can then come off daratumumab.
What happens next?
A positive recommendation from NICE means clinicians can start prescribing a treatment to eligible patients. A treatment should be made available to patients through the NHS within 90 days of the decision being published. However, it may take some time for the treatment to become available, depending on the treatment itself and the capacity of hospitals to deliver it.
What about people living in Scotland and Northern Ireland?
In Scotland, the Scottish Medicines Consortium makes decisions about which treatments to fund through the NHS. The SMC appraisals of DVRD for myeloma patients who can and cannot have a stem cell transplant will likely start later this year.
In Northern Ireland, the Department for Health can follow guidance issued by either NICE or the SMC but usually follows the guidance issued by NICE.
