UK regulator gives green light to combination for multiple myeloma

Myeloma cells

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.

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.

Approximately 24,000 people live with MM in the UK, and over 5,000 people in England and 260 in Wales are diagnosed annually.

“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.

Seven years of trial data

DLd is licensed and has been available for use in Europe since 2019. The positive Final Draft Guidance (FDG) follows a positive acceptance from the Scottish Medicines Consortium (SMC) for routine use in NHS Scotland this month.

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 III study comparing daratumumab plus lenalidomide and dexamethasone with lenalidomide plus dexamethasone.

“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.

“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.”

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