Nubeqa ® (darolutamide) receives EU approval as a new treatment for men with non-metastatic castration-resistant prostate cancer (for specialized target groups only)

Oral androgen receptor inhibitor (ARi) Nubeqa ® (darolutamide) approved for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease / Approval is based on Phase III ARAMIS trial results showing a statistically significant improvement in metastasis-free surviv al (MFS) for darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT, and a favorable safety profile
Source: Bayer Company News - Category: Pharmaceuticals Source Type: news