The National Institute for Health and Care Excellence (NICE) is backing NHS use of Janssen’s Darzalex via the Cancer Drugs Fund (CDF) for some adults with previously treated multiple myeloma.
Darzalex (daratumumab) is a humanised monoclonal antibody that works by binding to a signalling molecule found on the surface of multiple myeloma cells called CD38, to trigger the patient's own immune system to attack and kill the cancer cells.
NICE’s appraisal committee has ruled that the drug can not be recommended for routine use within its marketing authorisation for treating relapsed and refractory multiple myeloma in adults, because uncertainties in the clinical data available mean that cost effectiveness estimates are unreliable.
It did, however, feel that additional data collected through the CDF would provide more robust evidence on the clinical effectiveness of Darzalex compared with current treatment options.
As such, interim funding through the CDF has been approved by NICE – to treat relapsed and refractory multiple myeloma in adults whose disease has progressed despite three prior treatments, including proteasome inhibitor and an immunomodulator - to allow for the collection of additional data until November 2020, after which guidance will be reviewed.
Around 705 patients a year will be eligible for treatment with the drug in this setting, according to NICE.
Rosemarie Finley, Chief Executive of Myeloma UK, said: “This is excellent news for myeloma patients and their families. There is still significant unmet need in this patient population so approval of this exciting and innovative new therapy is extremely welcome. The ability to now use daratumumab with its known side effect profile in monotherapy might help patients that suffer under the cumulative side effects of previous treatments."