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Drug approval

Daratumumab recommended for treatment of multiple myeloma in Scotland

The Scottish Medicines Consortium (SMC) has recommended daratumumab (Darzalex) for use as a fourth-line treatment option in multiple myeloma.

The decision follows a re-submission by the drug’s manufacturer Janssen–Cilag, after it was previously rejected in January of this year, and is based on a patient access scheme to increase the cost effectiveness of daratumumab to the NHS in Scotland.

“I am pleased the committee has been able to accept daratumumab… for use by NHS Scotland,” said Alan MacDonald, chairman of the SMC. “[It] offers a further treatment option for those patients with multiple myeloma who have already had a number of previous treatments.”

The therapy is a monoclonal antibody that targets a protein called CD38 which is highly expressed on multiple myeloma tumour cells.

It is indicated as monotherapy for patients with relapsed and refractory disease, who must have previously been treated with a proteasome inhibitor and an immunomodulatory agent and progressed during their last therapy.

Key efficacy data submitted to the SMC came from a phase II and phase I/II trial that demonstrated an overall response rate of 31%, median progression-free survival of 4.0 months and overall survival of 20.1 months.

The acceptance also took into account input from a patient and clinician engagement meeting, which highlighted the limited treatment options available to patients at this stage of the disease.

“Patients need and deserve access to the best possible myeloma treatments and for that to happen the NHS needs to keep championing and supporting innovation. We are therefore delighted by the SMC’s decision,” said Rosemarie Finley, chief executive of the charity Myeloma UK.

“We were glad to play our part in enabling the SMC to reach its positive decision by ensuring that the patient and carer voices were heard in the process. We will keep working with the company and with drug approval bodies to gain access to this drug in other parts of the UK.”

Earlier this year, an appraisal by the National Institute for Health and Care Excellence (NICE) concluded that cost effectiveness estimates for the drug were unreliable and a committee was not able to recommend it in multiple myeloma.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203732

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  • Multiple myeloma ss oct 17

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