The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for darolutamide (Bayer and Orion), an investigational treatment for non-metastatic castration-resistant prostate cancer (nmCRPC).
Two-year and three-year biochemical progression-free survival rate of 100 percent for low-risk disease
Among men with nonmetastatic castration-resistant prostate cancer, those who were treated with darolutamide had a 59% decreased risk of metastasis compared with placebo recipients.
At a median follow-up of nearly 52 months, the treatment regimen deceased mortality risk among men with high-risk metastatic castration-naive prostate cancer by 30%.
After an additional 1 year of follow-up, apalutamide plus ADT continued to show a significant decrease in the risk of progression to metastasis or death.
At 23 years of follow-up, the cumulative incidence of death was higher among patients in the watchful waiting group compared with those in the radical prostatectomy group.
The study is the first to show that treatment with abiraterone acetate/enzalutamide is associated with better survival in African American patients with mCRPC compared with Caucasians.
By targeting prostate-specific membrane antigen, a molecule radiolabeled with lutetium-177 is expected to deliver high doses of beta radiation to distant metastases.
The Decipher genomic classifier predicted metastases and prostate cancer-specific mortality following radical prostatectomy with greater precision in African-American men.
Patients with metastatic CRPC and bone metastases treated with abiraterone plus prednisone/prednisolone had a higher risk of bone fractures when receiving concomitant radium-223.
