19 March 2019

NHS advisers in England have done an about-turn on the use of a monoclonal antibody treatment for relapsed multiple myeloma.

The National Institute for Health and Care Excellence (NICE) published their recommendation on 12th March. It states that daratumumab (sold as Darzalex) can be used together with bortezomib (Velcade) and dexamethasone, in a combination known as DVd.

In July last year, draft proposals had advised that the treatment would be rejected.

However, this three-drug regimen for multiple myeloma will only be made available to patients in England via the Cancer Drugs Fund, rather than as routine care on the NHS, whilst extra data on long-term survival is collected.

This drug combination could benefit up to 2,900 myeloma patients in England, say experts.

Professor Gordon Cook from St James's University Hospital, Leeds, said: “Myeloma is a relapse-remitting disease and after first relapse, patients can have a decreased response to treatment over time.

“For many patients, the first relapse can have a devastating physical and psychological impact, making it essential to use the most effective treatments as early as possible, to delay relapse and maximise overall survival.

“There is currently a huge unmet need for treatments in this set of patients, so the DVd combination is a long-awaited additional treatment option, which we anticipate to be game-changing for the myeloma community.”

In their guidance, NICE states that this drug combination has a “clinically important and statistically significant effect on progression-free survival”.

Shelagh McKinlay, Head of Patient Advocacy at the charity Myeloma UK, said: “This is really positive news and is a major step-change in the treatment available to patients at this stage in their myeloma.

“For too long there has been real unmet need at first relapse in myeloma. The limited treatment options, particularly for patients treated with bortezomib when newly diagnosed, has meant that patients were missing out at a critical time in their disease pathway.

“We are pleased to have contributed to this approval. We made sure the patient voice was heard by submitting evidence to NICE and encouraging decision makers to understand what access to this treatment means for patients and their families.”

The manufacturers Janssen said it was “disappointing” they were not able to secure routine access for the drug on the NHS.

Source: NICE / Myeloma UK


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