The Scottish Medicines Consortium (SMC) has approved the use of daratumumab (Darzalex®) monotherapy as a fourth line treatment option for relapsed and refractory myeloma patients in Scotland, who have previously received treatment with a proteasome inhibitor and immunomodulatory drug. This decision is based on the pooled analysis of results from two clinical trials, MMY2002 and GEN501, which showed an overall response rate of 31% in refractory patients receiving daratumumab.
Earlier this year, the National Institute for Health and Care Excellence (NICE) issued a draft guidance not recommending daratumumab monotherapy as a treatment for relapsed and refractory myeloma patients in England and Wales.