NICE approves new regimen for relapsed multiple myeloma


  • Dawn O'Shea
  • Oncology drug update
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

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.