The Lynx Group

Nubeqa Now Approved for Metastatic Hormone- Sensitive Prostate Cancer

October 2022, Vol 13, No 5


On August 5, 2022, the FDA accelerated the approval of darolutamide (Nubeqa; Bayer Healthcare), an androgen receptor inhibitor, in combination with docetaxel, for the treatment of metastatic hormone-sensitive prostate cancer in adults. Darolutamide was previously approved for the treatment of nonmetastatic castration-resistant prostate cancer.

This approval was based on the results of the randomized, multicenter, double-blind, placebo-controlled ARASENS phase 3 clinical trial that enrolled 1306 patients with metastatic hormone-sensitive prostate cancer. The patients received 600 mg of darolutamide orally twice daily plus 75 mg/m2 of docetaxel intravenously every 3 weeks for up to 6 cycles or docetaxel plus placebo.

The main outcomes measure was overall survival (OS). An additional efficacy measure was the time to pain progression. The median OS was not reached in the darolutamide plus docetaxel cohort and was 48.9 months (95% confidence interval [CI], 44.4-not reached) in the docetaxel plus placebo cohort (hazard ratio, 0.68; 95% CI, 0.57-0.80; P <.0001).

The most common (≥10% with a ≥2% increase over docetaxel plus placebo) adverse events were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. The most common (≥30%) laboratory abnormalities were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased aspartate aminotransferase, increased alanine aminotransferase, and hypocalcemia.

The recommended dose of darolutamide is 600 mg orally in two 300-mg tablets given twice daily with food until unacceptable toxicity or disease progression. The dose of docetaxel is 75 mg/m2 every 3 weeks for up to 6 cycles. The first dose of docetaxel should be given within 6 weeks of starting treatment with darolutamide.

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