General MM,   Relapsed/refractory patients

Daratumumab (darzalex) approved in Scotland

On 11 October 2017, the Scottish Medicines Consortium (SMC) approved the use of Darzalex® (daratumumab) as a monotherapy, for a subset of Multiple Myeloma (MM) patients who have had three previous lines of therapy. This prior treatment must include a proteasome inhibitor and an immunomodulatory agent (IMiD), and they must have progressed with the disease during their last therapy. This decision is restricted to this indication only and follows guidance from both the SMC and National Institute for Health and Care Excellence (NICE).

Data from two trials conducted by Janssen were reviewed by the committee: a Phase II trial (MMY2002) and a phase I/II dose-escalation study (GEN 501), for which a pooled analysis revealed an overall response of 31%. The cost-benefit analysis also took into account Janssen’s Patient Access Scheme (PAS), which helps to make this an affordable option for hospitals. This will give new hope to patients with Relapsed and Refractory MM in Scotland who fit these criteria, as effective treatment options at this late stage of the disease are limited.

Interestingly, this decision was in contrast to that made by NICE earlier this year, which rejected approval of daratumumab for the same indication on the basis of limited clinical data. It is hoped that NICE may review their decision later this year.

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