NICE has approved the use of daratumumab plus bortezomib plus dexamethasone within the Cancer Drugs Fund as a second-line treatment option for relapsed multiple myeloma.
The decision follows a public consultation on draft guidance issued in March and is supported by findings from the open-label CASTOR trial of daratumumab plus bortezomib plus dexamethasone compared with bortezomib plus dexamethasone. The results showed that the triple combination was associated with increased progression-free survival (PFS) compared to bortezomib plus dexamethasone (median 26 months vs 8 months) after a median follow-up of 27 months (hazard ratio [HR] 0.23; 95% CI 0.16-0.33; P
At the time of analysis, overall survival (OS) data was immature. At a median follow-up of 27 months, the data suggested that the addition of daratumumab to bortezomib and dexamethasone reduced the risk of death by 50% (HR 0.50; 95% CI 0.30-0.84; P=0.008).
Due to the lack of mature OS data and the absence of a direct comparison between daratumumab plus bortezomib plus dexamethasone and carfilzomib plus dexamethasone, the triple combination will not be routinely available on the NHS. The treatment will only be offered within the Cancer Drug Fund if the conditions of the managed access agreement are met.