Darzalex intravenous infusion. Credit: Myeloma UK.

The National Institute for Health and Care Excellence (NICE) has approved the use of immunotherapy drug daratumumab (Darzalex) on the National Health Service (NHS) for the treatment of myeloma patients in England and Wales, UK.

Manufactured by Janssen, daratumumab is a monoclonal antibody that directly binds to and destroys myeloma cells and/or leverages the body’s own immune system to kill them.

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Provided through the Cancer Drugs Fund (CDF), the approval indicates the drug as a monotherapy for patients who received three prior lines of treatment, including at least two specific myeloma drug types, and those who experienced disease progression on their last treatment.

The drug will be specifically available as a fourth line treatment option for relapsed and/or refractory myeloma.

“Myeloma UK has been working hard to secure access to daratumumab on the NHS and we are really pleased to have helped bring about this positive outcome for patients.”

Myeloma UK chief executive Rosemarie Finley said: “This is an important new treatment option for patients whose myeloma has come back and who may have exhausted other treatment options, or who are not responding well to other types of myeloma treatments.”

Under the approval, daratumumab is not indicated for patients who have previously had more than three lines of therapy.

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Finley added: “Myeloma UK has been working hard to secure access to daratumumab on the NHS and we are really pleased to have helped bring about this positive outcome for patients.

“However, we are disappointed that the current approval does not extend to patients who have had more than three previous lines of treatment and will continue discussions with NICE and with Janssen with the aim of widening future access.”