Recently, the Food and Drug Administration approved Darolutamide (Nubeqa) tablets in combination with chemotherapy, for patients with metastatic prostate cancer whose tumors are hormone-sensitive.

Darolutamide (given as tablets) is a type of hormone therapy. Hormone therapy is a common treatment for prostate cancer. The goal of this treatment is to reduce levels of male hormones, which stimulate the growth of prostate cancer cells in the body, or (Darolutamide) to stop them from fueling prostate cancer cell growth.

The approval is supported by results from a clinical trial which enrolled 1,306 patients with metastatic prostate cancer. Patients were randomly assigned to receive either chemotherapy intravenously administrated every 3 weeks for up to 6 cycles plus Darolutamide (study group), or the same schedule of chemotherapy plus placebo (control group). In both groups patients also received hormonal suppression therapy.

The study results point towards a significant lower risk of death among patients receiving Darolutamide (study group), compared to patients receiving placebo.

Moreover, treatment with chemotherapy plus Darolutamide resulted in significantly less pain for a longer time, compared to treatment with chemotherapy plus placebo.

Darolutamide provides a different treatment approach for patients with metastatic hormone-sensitive prostate cancer.