1.1 Darolutamide with androgen deprivation therapy (ADT) is recommended, within its marketing authorisation, as an option for treating hormone-relapsed prostate cancer in adults at high risk of developing metastatic disease. It is recommended only if the company provides darolutamide according to the commercial arrangement.
Why the committee made these recommendations
When prostate cancer no longer responds to hormone treatment (ADT), but has not spread beyond the prostate, the only current option is to continue ADT. Darolutamide added to ADT would be another option at this stage.
Clinical trial evidence shows that people taking darolutamide with ADT have more time before their prostate cancer spreads compared with ADT alone. Although the trial results suggest that darolutamide with ADT increases the length of time people live, it is unclear by how much in the long term.
Despite this, the cost-effectiveness estimates are within what NICE normally considers a cost-effective use of NHS resources. So darolutamide with ADT is recommended as an option.