The approval is based on Phase III results from the ARAMIS trial, which showed that men who took darolutamide in combination with androgen-deprivation therapy (ADT) had significant improvements in metastas is free survival. Men who took darolutamide had a median of 40.4 months of metastasis-free survival, compared to just 18.4 months in men who had a placebo and ADT. The study included approximately 1,500 patients who were randomized between the two groups.
Darolutamide (brand name Nubeqa) is an androgen-receptor inhibitor available as an oral medication taken twice daily. A phase III study evaluating the drug for use in men with metastatic hormone-sensitive prostate cancer is ongoing.
A high-risk type of cancer
Non-metastatic castration-resistant prostate cancer has not yet spread out of the prostate, but the disease is already resistant to hormonal therapy. Men with this type of prostate cancer are at high risk of developing metastatic disease. Their PSAs will continue to rise, indicating the cancer is continuing to grow, yet in the past they did not have access to drugs approved to target advanced metastatic prostate cancer.
Thankfully, research is leading to changes in available treatments for these men. In addition to darolutamide, the FDA recently approved apalutamide for men with this type of cancer.
Enzalutamide, which is already approved to treat metastatic castration-resistant prostate cancer, has shown to be effective for non-metastatic castration-resistant disease in the recent PROSPER trial.