1.1 Darolutamide with docetaxel is recommended, within its marketing authorisation, as an option for treating hormone-sensitive metastatic prostate cancer in adults. Darolutamide is only recommended if the company provides it according to the commercial arrangement.
Why the committee made these recommendations
Usual treatment for hormone-sensitive metastatic prostate cancer always includes androgen deprivation therapy (ADT), which may be given alone, or with docetaxel or enzalutamide. Darolutamide plus ADT and docetaxel would be another treatment option.
Clinical trial evidence shows that, compared with taking placebo plus ADT and docetaxel, people taking darolutamide plus ADT and docetaxel live longer, and have longer before their cancer gets worse or stops responding to ADT. There is also an indirect comparison comparing darolutamide plus ADT and docetaxel with usual treatment. The results suggest that darolutamide increases how long people live, and how long they have before their cancer gets worse or stops responding to ADT.
The cost-effectiveness estimates are within what NICE considers an acceptable use of NHS resources. So, darolutamide is recommended.