NICE issues Final Draft Guidance recommending DARZALEX® (daratumumab) with bortezomib, lenalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is unsuitable

The subcutaneous quadruplet regimen will become available on the NHS in England and Wales for eligible patients, expanding first-line treatment options for those who are unsuitable for a stem cell transplant¹

In the Phase 3 CEPHEUS trial, daratumumab with bortezomib, lenalidomide and dexamethasone demonstrated a higher overall minimal residual disease-negativity rate at a sensitivity of 10⁻⁵ (no cancer cells detected within 100,000 bone marrow cells) than bortezomib, lenalidomide and dexamethasone alone (60.9% versus 39.4%, respectively) at a median follow-up of 58.7 months, indicating deeper remission with the quadruplet regimen versus the triplet²

High Wycombe, UK (08 June 2026) – Johnson & Johnson is pleased that the National Institute for Health and Care Excellence (NICE) has recommended DARZALEX® (daratumumab) with bortezomib, lenalidomide and dexamethasone (D-VRd) for untreated multiple myeloma in adults when an autologous stem cell transplant (ASCT) is unsuitable, in its Final Draft Guidance.¹ This recommendation means that eligible patients can soon be treated with D-VRd – the only UK-licensed subcutaneous CD38-directed antibody combination for multiple myeloma – on the NHS in England and Wales.¹

Multiple myeloma is an incurable type of blood cancer affecting 33,000 people in the UK.3 Over time, myeloma becomes resistant to treatment, making it more difficult to treat with each relapse.¹ As a result, it is important that people with myeloma receive the most effective treatment at first-line, since subsequent lines of therapy may become less effective.¹ This is particularly important for those who are ineligible for an ASCT – accounting for approximately two-thirds of all newly-diagnosed myeloma patients – which is often considered the “gold standard” treatment.^1,4

“This is fantastic news and a hard-earned victory for patients who felt let down by NICE’s initial decision not to approve D-VRd,” said Caroline Donoghue, Access Manager at Myeloma UK. “We have been working very hard to get NICE to reconsider and we’re delighted they’ve agreed to roll it out on the NHS. We know how devastating being diagnosed with myeloma is and newly diagnosed patients deserve to have as many options available to them right from the off as it may mean less time spent in hospital for patients and their families. We can’t emphasise enough what this means for their quality of life. Until we have a cure, it is absolutely vital that people with myeloma get the treatment they need as soon as they’re diagnosed."*

“Bortezomib is a well-known therapy, and its addition to the daratumumab plus lenalidomide and dexamethasone triplet regimen is a great example of how a small change can have a big impact,” said Professor Supratik Basu, Haematology Consultant, The Royal Wolverhampton NHS Trust and University. “Having proudly been an investigator in the CEPHEUS trial in Wolverhampton, I’ve seen first-hand just how important it is that transplant-ineligible myeloma patients, who represent the majority of the myeloma population, have as many treatment options available to them as possible in the first-line setting. The availability of a generally well-tolerated new quadruplet regimen that has the same ease of administration and favourable outcomes as the triplet regimen will be welcome news to eligible patients. I’m very pleased to have led the research that made NICE’s positive outcome possible."*

NICE’s recommendation of D-VRd is based on data from CEPHEUS, a Phase 3, randomised, multicentre, open-label trial comparing the efficacy and safety of D-VRd with bortezomib, lenalidomide and dexamethasone (VRd) alone in patients with newly-diagnosed transplant-ineligible or transplant-deferred multiple myeloma.² The primary endpoint was overall minimal residual disease (MRD)-negativity rate at a 10⁻⁵ sensitivity threshold as measured by next-generation sequencing.² At a median follow-up of 58.7 months, the overall MRD-negativity rate was 60.9% with D-VRd versus 39.4% with VRd (odds ratio, 2.37; 95% confidence interval (CI), 1.58–3.55; P < 0.0001), indicating patients in the D-VRd arm achieved a deeper remission than those in the VRd arm.² Adverse events were consistent with the known safety profiles for daratumumab and VRd; the most common (>10%) grade 3 or 4 treatment-emergent adverse events (TEAEs) for D-VRd compared to VRd were neutropenia (44.2% versus 29.7%) and thrombocytopenia (28.4% versus 20.0%), while the rate of treatment discontinuation caused by TEAEs was 7.6% for D-VRd and 15.9% for VRd.²

Standard of care treatment options in the UK for newly-diagnosed transplant-ineligible multiple myeloma include daratumumab in combination with lenalidomide and dexamethasone (DRd) and isatuximab in combination with bortezomib, lenalidomide and dexamethasone (isa-VRd).¹ The NICE recommendation was based on evidence provided in support of DVRd being a cost effective use of NHS resources when considered against UK standard of care.¹

“We are delighted that D-VRd is now available on the NHS to eligible patients with multiple myeloma who are not suitable to receive a stem cell transplant,” said Nina Pinwill, UK Director of Strategic Access, Pricing and Operations, Johnson & Johnson. “J&J’s long-standing heritage in myeloma means we know just how important it is for patients to have as many first-line treatment options available to them as possible. I would like to say a massive thank you to everyone involved in the appraisal process who helped to bring about this positive outcome, which I hope comes as welcome news to the patient community and their loved ones.”

#ENDS#

About the CEPHEUS study²
CEPHEUS is a Phase 3, randomised, multicentre, open-label trial comparing the efficacy and safety of D-VRd with VRd alone in patients with newly-diagnosed multiple myeloma who were transplant-ineligible or for whom transplant was not planned as the initial therapy (transplant-deferred). The primary endpoint was overall MRD-negativity rate at a 10⁻⁵ sensitivity threshold as measured by next-generation sequencing, with major secondary endpoints being overall complete response (CR) or better rate, PFS and sustained MRD-negativity rate at one year.

At a median follow-up of 58.7 months, the overall MRD-negativity rate was 60.9% with D-VRd versus 39.4% with VRd (odds ratio, 2.37; 95% CI, 1.58–3.55; P < 0.0001). Rates of ≥CR (81.2% versus 61.6%; P < 0.0001) and sustained MRD negativity of ≥12 months (48.7% versus 26.3%; P < 0.0001) were significantly higher with D-VRd versus VRd. The risk of progression or death was 43% lower for D-VRd compared to VRd (hazard ratio, 0.57; 95% CI, 0.41–0.79; P = 0.0005).

The most common TEAEs of any grade for D-VRd compared to VRd were diarrhoea (56.9% versus 59%), neutropenia (55.8% versus 39%), peripheral sensory neuropathy (55.8% versus 61%), thrombocytopenia (46.7% versus 33.8%) and peripheral edema (42.1% versus 39%). The most common (>10%) grade 3 or 4 TEAEs for D-VRd compared to VRd were neutropenia (44.2% versus 29.7%) and thrombocytopenia (28.4% versus 20%). Serious TEAEs occurred in 72.1% of patients in the D-VRd arm and 67.2% in the VRd arm. The most common serious TEAE was pneumonia (13.7% for D-VRd versus 12.8% for VRd). The rate of treatment discontinuation caused by TEAEs was 7.6% for D-VRd and 15.9% for VRd.

About daratumumab
Daratumumab is a human monoclonal antibody targeting the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells.⁵ Daratumumab works by binding to CD38 and inhibiting tumour cell growth, thereby helping to destroy myeloma cells.⁵

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.⁶

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.⁷ The five-year survival rate for adults with multiple myeloma in England and Wales is estimated to be 56%.⁸

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 https://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.

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*Caroline Donoghue and Professor Basu have not been paid for any media work.