NICE issues Final Draft Guidance recommending DARZALEX® (daratumumab) plus bortezomib, lenalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is suitable

With NICE’s Final Draft Guidance (FDG), this quadruplet therapy is set to become available on the NHS in England and Wales, offering an additional first-line induction treatment option before patients receive an autologous stem cell transplant, followed by consolidation and daratumumab plus lenalidomide maintenance.¹

NICE’s FDG is based on results from the Phase 3 PERSEUS trial, which met its primary endpoint of progression-free survival (PFS), showing a 58% reduction in risk of disease progression or death for daratumumab plus bortezomib, lenalidomide and dexamethasone induction and consolidation therapy, followed by daratumumab plus lenalidomide maintenance treatment, compared to bortezomib, lenalidomide and dexamethasone induction and consolidation therapy followed by lenalidomide maintenance.²

High Wycombe, UK (10 September 2026) – Johnson & Johnson has today announced that the National Institute for Health and Care Excellence (NICE) has published Final Draft Guidance recommending DARZALEX® (daratumumab) plus bortezomib, lenalidomide and dexamethasone (D-VRd) followed by daratumumab plus lenalidomide maintenance treatment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.¹ 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.¹ In addition, NICE’s guidance 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.¹

“Step change” in the management of myeloma

Importantly, NICE has also recommended an innovative minimal residual disease (MRD)-guided approach to treatment.¹ 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.¹ 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.¹

Unmet treatment need for transplant-eligible patients with newly diagnosed multiple myeloma

Around 33,000 people in the UK are currently living with multiple myeloma, an incurable type of blood cancer.³ As a relapsing-remitting condition, myeloma becomes more resistant to treatment over time.¹ 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.¹ The disease carries a large psychological impact because of the constant possibility of relapse.¹

The NICE recommendation also addresses a longstanding unmet need for a thalidomide-sparing quadruplet treatment option for transplant-eligible patients.¹ NICE recognised that the use of lenalidomide in place of thalidomide is associated
with a lower risk of peripheral neuropathy, representing an additional patient benefit beyond those captured in the economic modelling.¹ Further, the NICE committee noted that additional first-line treatment options are especially important for patients eligible for ASCT, since they tend to be younger, more likely to be working and often have caring responsibilities, meaning the disease can have a particularly detrimental impact on them and their loved ones.¹

PERSEUS clinical trial data

NICE based the recommendation in its Final Draft Guidance on data from PERSEUS, a Phase 3, randomised, multicentre, open-label trial comparing the efficacy and safety of D-VRd induction and consolidation therapy followed by daratumumab plus lenalidomide maintenance treatment (D-VRd group), with bortezomib, lenalidomide and dexamethasone (VRd) induction and consolidation therapy and lenalidomide maintenance (VRd group) in patients with newly-diagnosed multiple myeloma who are eligible for an ASCT.² The primary endpoint was progression-free survival (PFS).² At a median follow-up of 47.5 months, the D-VRd group was found to have a statistically significant reduction in risk of disease progression or death compared to the VRd group (hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.30-0.59; P <0.001).²

The safety profile of D-VRd was consistent with the known safety profiles for daratumumab and VRd in this patient population.² Grade 3 or 4 adverse events occurred in most patients in both groups; the most common were neutropenia
(62.1% with D-VRd and 51.0% with VRd) and thrombocytopenia (29.1% and 17.3%, respectively).² Adverse events that led to treatment discontinuation were reported in 8.8% of the patients in the D-VRd group and 21.3% of those in the VRd group.²

Expert and company perspectives on NICE’s Final Draft Guidance

“This is fantastic news and shows that personalised treatment is absolutely the future of myeloma care,” said Scott Purdon, Head of Patient Advocacy at Myeloma UK. “D-VRd has been shown to deliver long and deep responses for myeloma. As a subcutaneous regimen, it is also more convenient and flexible than intravenous infusions and the introduction of MRD testing during maintenance treatment could mean less time spent in hospital for people with myeloma and their families compared to the previous standard of care – which is something that we know people want. We’ve worked for nearly 18 months to get this treatment made available on the NHS because we believe that people with myeloma deserve faster and fairer access to the treatments they so desperately need. 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.”

“The substitution of lenalidomide for thalidomide will have benefit in terms of less frequent incidence of neurotoxicity
and improved depth response. Secondly, access to dual agent maintenance with both daratumumab and lenalidomide will drive improvements in progression free survival, depth of response including MRD negativity and quality of life which is improved in line with duration of remission,” said Dr Ceri Bygrave, Consultant Haematologist (Cardiff & Vale), and UK Myeloma Society Advocacy Lead. “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. The UK now stands in line with leading centres in the rest of the world with access to quadruplet induction and doublet maintenance for newly diagnosed patients of all ages across the treatment pathway. This achievement would not have taken place without the support of all patients and wider stakeholders involved in this work. Thank you to them all on behalf of the UK Myeloma Society.”

“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. I’d like to thank everybody who contributed to the appraisal process for their diligence and commitment to improving outcomes for these patients, who are central to our ambition of getting in front of, and one day eliminating, blood cancer.”

#ENDS#

About the PERSEUS study²
PERSEUS is a Phase 3, randomised, multicentre, open-label trial comparing the efficacy and safety of D-VRd induction and consolidation therapy followed by daratumumab plus lenalidomide maintenance treatment (D-VRd group), with VRd induction and consolidation therapy and lenalidomide maintenance (VRd group) in patients with newly-diagnosed multiple myeloma who are eligible for an ASCT. The primary endpoint was PFS, and secondary endpoints included complete response (CR) or better rate, overall minimal residual disease (MRD)-negativity rate (in patients with CR or better), overall survival (OS), sustained MRD-negativity rate and safety.

At a median follow-up of 47.5 months, the primary efficiacy endpoint of PFS was met, with the D-VRd group [N=355] showing a 58% reduction in risk of progression or death compared to the VRd group [N=354] (HR, 0.42; 95% CI, 0.30-0.59; P <0.001). Median PFS was not reached in either arm (meaning more than half of patients hadn’t experienced disease worsening or death); the estimated percentage of patients with PFS at 48 months was 84.3% in the D-VRd group (95% CI, 79.5-88.1) versus 67.7% in the VRd group (95% CI, 62.2-72.6). The MRD-negativity rate assessed at a sensitivity of 10-5 (no cancer cells detected within 100,000 bone marrow cells) was 75.2% versus 47.5% (P <0.001), CR or better rate was 87.9% versus 70.1% (P <0.001), and sustained MRD-negativity for ≥12 months was 64.8% versus 29.7%, for the D-VRd group versus the VRd group. OS data were immature (meaning more than half of patients were still alive in both arms), with death occuring in 34 patients in the D-VRd group (9.6%) and 44 patients in the VRd group (12.4%).

The most common grade 3 or 4 adverse events were neutropenia (62.1% in the D-VRd group and 51.% in the VRd group), thrombocytopenia (29.1% and 17.3%, respectively), diarrhea (10.5% and 7.8%), pneumonia (10.5% and 6.1%), and febrile neutropenia (9.4% and 10.1%). Grade 3 or 4 peripheral neuropathies occurred in 6% of the patients in the D-VRd group and 4.9% of those in the VRd group. Serious adverse events occurred in 57% of the patients in the D-VRd group and 49.3% of those in the VRd group. The most common serious adverse event was pneumonia (11.4% in the D-VRd group and 6.1% in the VRd group). Adverse events that led to treatment discontinuation were reported in 8.8% of the patients in the D-VRd group and 21.3% of those in the VRd group.

About daratumumab
Daratumumab is a human monoclonal antibody targeting the CD38 protein, which is highly expressed on the surface of multiple myeloma cells.⁴ Daratumumab works by binding to CD38 and triggering immune-mediated killing of multiple myeloma cells thus helping to block tumour growth.⁴

In the UK, daratumumab subcutaneous injection is indicated:

• in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly-diagnosed multiple myeloma who are ineligible for ASCT;
• in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma;
• in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for ASCT;
• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy;
• in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide‑refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy;
• as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy;
• as monotherapy for the treatment of adult patients with smouldering multiple myeloma at high risk of developing
  multiple myeloma;
• in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly-diagnosed systemic light chain (AL) amyloidosis.⁵

In August 2012, Janssen Biotech, Inc. entered into a global license and development agreement with Genmab A/S, which granted Janssen Biotech, Inc. an exclusive license to develop, manufacture and commercialise daratumumab.

About multiple myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.³ When damaged, these plasma cells rapidly spread and replace normal cells with tumours.³ In the UK, there are around 6,200 new multiple myeloma cases diagnosed every year, and over 33,000 people are living with the condition.³ While some patients with multiple myeloma initially show no signs of the disease, most patients are diagnosed due to symptoms that can include bone disease or pain, frequent infections, tiredness, peripheral neuropathy, high calcium levels or kidney problems.⁶ The five-year survival rate for adults with multiple myeloma in England and Wales is estimated to be 56%.⁷

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at www.jnj.com/innovativemedicine/uk/

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© Janssen-Cilag Limited, a Johnson & Johnson company. All rights reserved.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

*Myeloma UK and Dr Ceri Bygrave have not been paid for any media work.

September 2026 | CP-601029