Nubeqa (darolutamide) has been authorised for use alongside androgen deprivation therapy (ADT). According to Bayer, it is the first treatment NICE has recommended in this indication.
The NICE recommendation is based on results from the phase III ARAMIS trial, which evaluated the efficacy and safety of Nubeqa plus ADT in nmCRPC patients.
In this trial, Nubeqa plus ADT demonstrated a statistically significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median 40.4 months compared to 18.4 months for placebo plus ADT…