FDA Approves Oral Darolutamide/Docetaxel for Metastatic HSPC

Patients with metastatic hormone-sensitive prostate cancer can now receive treatment with oral darolutamide plus docetaxel following its approval by the FDA.

The FDA has granted approval to oral darolutamide (Nubeqa) in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer, according to a press release from the organization.

The approval was based on findings from the phase 3 ARASENS study (NCT02799602), which demonstrated a statistically significant and clinically meaningful improvement in overall survival with darolutamide plus docetaxel compared with the chemotherapy (HR, 0.68; 95% CI, 0.57-0.80; P <.0001). At a median of 43.7 months of follow-up, the median OS was not reached with darolutamide/docetaxel vs 48.9 months with chemotherapy. The experimental regimen also yielded a statistically significant delay in time to pain progression vs the control arm (HR, 0.79; 95% CI, 0.66-0.95; 1-sided P = .006).

The trial included a total of 1306 patients who were randomized to received either 600 mg of darolutamide twice daily plus 75 mg/m2 of intravenous docetaxel every 3 weeks for up to 6 cycles or matched placebo plus docetaxel. Concurrent gonadotropin-releasing hormone analog or bilateral orchiectomy was given in all patients

Common adverse effects included constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension, and frequent laboratory abnormalities included anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased aspartate aminotransferase and alanine transaminase, and hypocalcemia.


FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer. News release. August 5, 2022. Accessed August 5, 2022. https://bit.ly/3bvsKzF