By PPN News Staff
The FDA approved darolutamide (Nubeqa, Bayer), an androgen receptor inhibitor (ARi), for the treatment of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC).
Approval was based on ARAMIS, a multicenter, double-blind, placebo-controlled clinical trial evaluating darolutamide plus androgen deprivation therapy (ADT), in 1,509 patients with nmCRPC. Patients were randomly assigned to receive either 600 mg of darolutamide orally twice daily (n=955) or