European Commission grants marketing authorisation for darolutamide (Nubeqa), for certain men with non-metastatic castration-resistant prostate cancer

Approved based on Phase III ARAMIS trial which demonstrated a significant improvement in the primary efficacy endpoint of metastasis-free survival, with a median outcome of 40.4 months, versus 18.4 months for placebo plus androgen deprivation therapy.

Source:

PharmaTimes