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National Institute for Health and Care Excellence says ‘yes’ to Darzalex®▼ (daratumumab) for relapsed and refractory multiple myeloma

National Institute for Health and Care Excellence says ‘yes’ to Darzalex® (daratumumab) for relapsed and refractory multiple myeloma


High Wycombe, 15th March 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson welcomes the decision by the National Institute for Health and Care Excellence (NICE) which recommends the use of Darzalex® (daratumumab) monotherapy for adult patients with relapsed and refractory multiple myeloma that has previously been treated with three therapies, including a proteasome inhibitor and an immunomodulator, and who have demonstrated disease progression on the last therapy.[1]


The positive Final Appraisal Document (FAD) follows over four years of continued use of daratumumab monotherapy in England for treating relapsed and refractory multiple myeloma, after it was initially recommended for use through the Cancer Drugs Fund (CDF) in 2018.[2] Since its availability via the CDF, real-world evidence has been collected via Systemic Anti-Cancer Therapy (SACT) data to provide additional certainties of benefit.1 This was supplemented with final analyses from the Phase II registrational study MMY2002, after a median follow-up of 36.7 months, to inform the reappraisal at the end of the CDF funding period.1


Amanda Cunnington, Director of Patient Access, Janssen-Cilag Limited said: “Today’s decision to recommend daratumumab for routine commissioning on the NHS is welcome news. We appreciate the rapid and pragmatic way NICE have reappraised daratumumab, taking account of real-world evidence and lived experience from patients. This positive FAD demonstrates how through close collaboration, there is opportunity to work with the UK system to provide greater certainties on medicines.”


Although treatable, multiple myeloma is an incurable blood cancer.[3] When the disease becomes refractory – meaning initial treatments have stopped working – the prognosis can be poor.2  A range of treatment options are therefore needed, and the routine funding of daratumumab will bring this group of patients a generally well-tolerated and effective option at this line of the treatment pathway.1


Commenting on the recommendation, Shelagh McKinlay, Acting Director of Research and Patient Advocacy at Myeloma UK said: “Living with myeloma is a constant race against the clock, and with every relapse, treatment options can become more limited. That’s why delivering treatments as soon as possible makes a tremendous difference to patients’ quality of life and life expectancy. Today’s recommendation is a great example of how charities, pharmaceutical companies and NICE can work together to give patients access to effective treatments as efficiently as possible.”

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Last Updated: 17-Mar-2022