FDA Approves Darolutamide Combination for Metastatic Hormone-Sensitive Prostate Cancer

By: JNCCN 360 Staff
Posted: Tuesday, August 30, 2022

On August 5, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa) tablets in combination with docetaxel for adults with metastatic hormone-sensitive prostate cancer. The androgen receptor inhibitor was approved for treatment of nonmetastatic castration-resistant prostate cancer in 2019.

The current regulatory decision was supported by findings from the phase III ARASENS trial (ClinicalTrials.gov identifier NCT02799602), in which darolutamide plus docetaxel improved median overall survival compared with docetaxel alone. The median overall survival with darolutamide plus docetaxel was not yet reached versus 48.9 months with docetaxel alone (hazard ratio [HR] = 0.68; 95% confidence interval [CI] = 0.57–0.80; P < .0001). In addition, treatment with darolutamide plus docetaxel significantly delayed the time to pain progression (HR = 0.79; 95% CI = 0.66–0.95; one-sided P = .006).

The randomized, multicenter, double-blind, placebo-controlled ARASENS trial enrolled a total of 1,306 patients with metastatic hormone-sensitive prostate cancer. They were randomly assigned to receive oral darolutamide at 600 mg twice daily in combination with intravenous docetaxel at 75 mg/m² every 3 weeks for up to six cycles or docetaxel alone. All participants were given gonadotropin-releasing hormone analog concurrently or underwent a bilateral orchiectomy.

The most common adverse effects experienced by patients who received the combination regimen included constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. The most frequently experienced laboratory test abnormalities, occurring in 30% or more of treated patients, were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased aspartate and alanine aminotransferase levels, and hypocalcemia.

U.S. Food and Drug Administration

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