NICE has approved daratumumab plus bortezomib plus dexamethasone (DBD) for use within the Cancer Drugs Fund (CDF) as an option for the second-line treatment of relapsed multiple myeloma.
The decision is based on data from the open-label CASTOR trial which compared the combination with bortezomib plus dexamethasone.
There was an increase in progression-free survival (PFS) with DBD (median 26 months) compared with bortezomib plus dexamethasone (median 8 months) after a median follow-up of 27 months (hazard ratio [HR] 0.23; 95% CI 0.16-0.33; P
At the pre-specified interim analysis point, overall survival (OS) data from CASTOR were immature. The available data showed that DBD reduced the risk of death by 50% compared with bortezomib plus dexamethasone (HR 0.50; 95% CI 0.30-0.84; P=0.008). However, the long-term OS benefit remains unknown.
Because of the uncertainty regarding the long-term OS, the estimates of cost-effectiveness presented by the company and NICE differed significantly. If the company's estimates are confirmed by extra trial data, there is potential for triple-therapy to be cost-effective. In the meantime, the treatment is approved for use in the CDF while data on long-term survival are collected.