- Daratumumab combination is recommended for use within the NHS for newly diagnosed systemic amyloid light-chain (AL) amyloidosis1
- Eligible individuals throughout England and Wales can now access the first licenced treatment for people living with this life-threatening disease1
- AL amyloidosis is a rare and incurable bone marrow disorder that affects up to 600 people in the UK annually, and can cause serious organ damage1,2
High Wycombe, 29 February 2024 – The Janssen Pharmaceutical Companies of Johnson & Johnson is pleased to announce that the National Institute for Health and Care Excellence (NICE) has recommended DARZALEX® (daratumumab) plus VELCADE® (bortezomib), cyclophosphamide and dexamethasone (DVCd) as an option for newly diagnosed systemic amyloid light-chain (AL) amyloidosis.1 DVCd is recommended subject to a commercial agreement, and only if daratumumab is stopped after 24 cycles of treatment, or earlier if the condition progresses.1 This positive decision follows an extensive appraisal process including an appeal against the original guidance from NICE in November 2022, and means that eligible individuals throughout England and Wales can now access the first licenced treatment for this disease.1,3
Amyloid light-chain (AL) amyloidosis is a rare and incurable bone marrow disorder that affects up to 600 people in the UK annually, and can cause life-threatening organ damage.1,2 The condition can seriously affect an individual’s physical and mental health, and those with the most severe forms of AL amyloidosis can present with heart and renal failure.1 People with AL amyloidosis face considerable unmet needs due to the poor outcomes often associated with the current standard of care, which includes chemotherapy and a stem cell or bone marrow transplant.1
“This is tremendous news and means that for the very first time people who have AL amyloidosis will be able to gain access to this treatment combination. I want to extend my heartfelt thanks to everyone who has fought alongside us. Every person who has written to their MP, shared their story and helped us make the case to NICE about this significant unmet need and the huge impact it will have,” said Dr. Sophie Castell, Chief Executive, Myeloma UK.* “Although we’re immensely proud of what we’ve achieved together, we are mindful that over the last year, while we pushed for a U-turn on NICE’s decision, hundreds of newly-diagnosed patients missed out on this treatment – a treatment which has been available in Scotland and Northern Ireland since 2022. It’s disappointing that it took so long to get to this point. We will continue to push for the system to work faster and deliver for those who need it most.”
The DVCd regimen is an effective and generally well-tolerated treatment that increases the time until systemic AL amyloidosis worsens compared to bortezomib, cyclophosphamide and dexamethasone alone.1 Before the NICE acceptance of DVCd, there were no licensed treatment options available for people with the condition in England and Wales, although DVCd has been available on the NHS in Scotland and Northern Ireland since 2022.4,5
“We are so pleased to have reached this outcome for those with AL amyloidosis. To date, there have been limited options for those suffering with the symptoms of this serious condition,” said Amanda Cunnington, Senior Director of Patient Access, Janssen-Cilag Limited. “This decision means that people in England and Wales can finally access the first licensed treatment for AL amyloidosis on the NHS. The commitment and drive of all stakeholders involved has been critical to achieving this outcome, and we hope that the progress made here shows what is needed for the UK healthcare system and the pharmaceutical industry to work together to address unmet needs for patients with rare diseases.”
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About daratumumab
Daratumumab is a human monoclonal antibody targeting the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells.6
It is licensed for use in the UK:
- 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 autologous stem cell transplant.7,8
- in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.7,8
- 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.7,8
- 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.7
- 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.7,8
- in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis.7
In August 2012, Janssen Biotech, Inc. entered into a global license and development agreement with Genmab A/S, which granted Janssen an exclusive license to develop, manufacture and commercialise daratumumab.
Important safety information
For a full list of side effects and information on dosage and administration, contraindications and other precautions when using daratumumab, please refer to the Summary of Product Characteristics for further information.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism, & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.
Learn more at www.janssen.com/uk. Follow us at www.twitter.com/JanssenUK. Janssen- Cilag Limited is a Janssen Pharmaceutical Company of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding 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 Janssen Research & Development, LLC, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including 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 Annual Report on Form 10-K for the fiscal year ended January 2, 2022, 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 or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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