National Institute for Health and Care Excellence gives green light to Darzalex® (daratumumab) with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma

• Daratumumab combination is recommended for use within the NHS in England and Wales for treating adults with newly diagnosed multiple myeloma where a stem cell transplant is unsuitable
• Eligible patients throughout England and Wales can now access alternative combination treatment option which has been shown to delay disease progression and extend life-expectancy

High Wycombe, 22 September 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson are pleased to announce that the National Institute for Health and Care Excellence (NICE) has recommended Darzalex^® (daratumumab) in combination with lenalidomide and dexamethasone (DLd) for untreated multiple myeloma (MM) for routine use on the NHS in England and Wales.[1] The therapy is now recommended within an NHS setting for the treatment of adults with newly diagnosed MM where an autologous stem cell transplant (ASCT) is unsuitable.¹

Multiple myeloma is a treatable but incurable blood cancer arising in plasma cells, with approximately 24,000 people living with the disease in the UK, and over 5,000 people in England and 260 in Wales diagnosed annually.[2]^,[3] The disease can significantly impact patients’ quality of life, with bone pain and fractures, anaemia, recurring infections, kidney dysfunction and nerve damage all possible presenting features.^1,[4] Among the potential treatment options is ASCT, an intensive therapy which can improve survival.[5] However, many patients are not candidates to receive or unable to tolerate ASCT, which means access to other well-tolerated treatment options are crucial to improving survival of patients.¹

“DLd is a game changer that will make a tremendous difference to patients’ quality of life and help to close the gap in survival between people who are eligible for a stem cell transplant and those who are not. Not only has DLd been shown to nearly double current remission times, but it gets myeloma under control faster. Approximately two-thirds of newly-diagnosed myeloma patients are not eligible for a transplant, and now, at long last, they’ll be able to benefit from a potentially life-extending treatment that could give them precious time with their loved ones,” said Shelagh McKinlay, Director of Research and Advocacy at blood cancer charity Myeloma UK.* “We will continue to campaign to make sure that people living with myeloma receive access to the latest, most effective treatments when they need them, and we are committed to working with NICE, NHS England and other key partners towards this goal. Until we find a cure, it is vital that all myeloma patients are allowed to live a full life for as long as possible.”

DLd is licensed and has been available for use in Europe since 2019.[6] The positive Final Draft Guidance (FDG) follows a positive acceptance from the Scottish Medicines Consortium (SMC) for routine use in NHS Scotland this month.[7] NICE’s decision to recommend DLd is based on approximately seven years of data from the ongoing registrational MAIA trial, an international, randomised, parallel group, open-label, Phase 3 study comparing daratumumab plus lenalidomide and dexamethasone (n=368) with lenalidomide plus dexamethasone (n=369).^1,[8]

“We are delighted that eligible patients in England are now able to access this much needed combination therapy, which has been shown to improve outcomes by delaying the progression of disease and extending life-expectancy,” said Amanda Cunnington, Senior Director of Patient Access and Health Affairs, Janssen-Cilag Limited. “We have worked diligently with NICE and NHS England over a number of years to navigate system challenges and achieve this outcome for patients. We hope that with further evolution of the access system in the UK and continued collaborations such as this, the UK life sciences industry can continue its efforts to address unmet needs for people living with blood cancer.”

*Shelagh McKinlay, Myeloma UK, has provided this quote voluntarily, and neither she nor others at Myeloma UK have been compensated for any media work.

[1] National Institute for Health and Care Excellence. Final Draft Guidance. Daratumumab with lenalidomide and dexamethasone for untreated multiple myeloma when stem cell transplant is unsuitable.

[2] Myeloma UK. What is myeloma? Available at https://www.myeloma.org.uk/understanding-myeloma/what-is-myeloma. Last accessed September 2023.

[3] Cancer Research UK. Myeloma incidence statistics. Available at https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/myeloma/incidence#heading-Zero. Last accessed September 2023.

[4] Myeloma UK. Symptoms and complications. Available at https://www.myeloma.org.uk/understanding-myeloma/symptoms-and-complications. Last accessed September 2023.

[5] Parrondo RD, Ailawadhi S, Sher T, Chanan-Khan AA, Roy V. Autologous Stem-Cell Transplantation for Multiple Myeloma in the Era of Novel Therapies. JCO Oncol Pract. 2020;16(2):56-66.

[6] European Medicines Agency. Darzalex Assessment Report 2019. Available at https://www.ema.europa.eu/en/documents/variation-report/darzalex-h-c-4077-ii-0029-epar-assessment-report-variation_en.pdf. Last accessed September 2023.

[7] Scottish Medicines Consortium. Daratumumab in combination with lenalidomide and dexamethasone (DLd) is licensed for use for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). September 2023.

[8] Moreau P et al. Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Transplant-Ineligible Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM): Clinical Assessment of Key Subgroups of the Phase 3 Maia Study. Blood. 2022;140 (Supplement 1):7297–7300.