The National Institute of Health and Care Excellence (NICE) has approved the use of daratumumab (Darzalex®) monotherapy as a treatment for relapsed and refractory myeloma patients. This treatment will be made available through the Cancer Drugs Fund (CDF) to patients in England and Wales who have received 3 prior treatments, including a proteasome inhibitor and an immunomodulatory drug.
This decision is based upon data from 2 Phase II trials, MMY2002 and GEN501, which demonstrate a good response among relapsed and refractory patients to daratumumab monotherapy. However, the data on overall survival remains immature, therefore until further data is gathered, this treatment will only be available through the CDF.
The Scottish Medicines Consortium (SMC) approved daratumumab monotherapy under the same restrictions in October last year.