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NICE approval for Janssen’s Darzalex combination



Recommendation concerns routine use across the NHS as therapy for multiple myeloma

The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that the National Institute for Health and Care Excellence (NICE) has recommended Darzalex with bortezomib and dexamethasone (DVd) for treating multiple myeloma.

The therapy – also known as daratumumab – will be routinely used throughout the NHS among adults who have had a single previous treatment which included lenalidomide or when lenalidomide was not considered suitable as a second treatment.

NICE’s decision regarding DVd has emerged following data from the phase 3 CASTOR study, which established the primary source of clinical effectiveness evidence. This data was duly complemented by real-world evidence which was accumulated through systemic anti-cancer therapy dataset in order to deliver survival outcomes expected in clinical practice across England.

Positive final draft guidance follows around four years of DVd use in England for the treatment of patients with relapsed multiple myeloma, after the initial approval of the biologic therapy for use via the Cancer Drugs Fund in 2019.

Dr Sophie Castell, chief executive at Myeloma UK, was encouraged about wider patient prospects following the recommendation: “DVd is a game-changer for myeloma patients and we’re delighted by NICE’s decision to make it permanently available to patients on the NHS. Over the past four years, many patients have benefitted from DVd through the Cancer Drugs Fund with some really promising results.”

She added: The combination has been shown to increase remission times by more than two years on average, giving patients whose cancer has sadly returned after their initial round of treatment a chance to enjoy more precious time with their loved ones and a semblance of normality.”

Amanda Cunnington, senior director of patient access at Janssen-Cilag Limited, reflected: “The decision to recommend daratumumab in combination with bortezomib and dexamethasone for routine use on the NHS is welcome news. This brings security to patients and clinicians that access to this significant advancement in the multiple myeloma treatment pathway in England will be maintained.”

She concluded: “Although treatable, multiple myeloma is an incurable blood cancer which becomes more resistant to treatment with each relapse – meaning access to a range of treatment options is needed. Routine commissioning of DVd will bring patients an effective and generally well-tolerated option.”

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