Oral darolutamide (Nubeqa™) is a novel second-generation, nonsteroidal, 
selective androgen receptor (AR) inhibitor indicated for the treatment of 
non-metastatic castration-resistant prostate cancer (nmCRPC). In the pivotal 
multinational, phase 3 ARAMIS trial in men with nmCRPC, relative to placebo plus 
ongoing androgen deprivation therapy (ADT), darolutamide (+ ADT) significantly 
prolonged metastasis-free survival (MFS) at the time of the primary analysis and 
overall survival (OS) at the time of the final OS analysis and was generally 
well tolerated in extended follow-up. Albeit long-term data from the real-world 
setting are required to fully define the safety profile of darolutamide, current 
evidence from the final ARAMIS analysis indicates that darolutamide has a low 
propensity for CNS-related adverse events (AEs) associated with other currently 
approved second-generation AR inhibitors. Given the efficacy and safety evidence 
from the final ARAMIS analysis and the key role of second-generation AR 
inhibitors in the management of nmCRPC, darolutamide + ADT represents an 
important emerging option for the treatment of men with nmCRPC who are at high 
risk of developing metastatic prostate cancer.