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FDA Approves Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer


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ON JULY 30, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa) for the treatment of nonmetastatic castration-resistant prostate cancer.

Approval was based on the ARAMIS study, a multicenter, double-blind, placebo-controlled clinical trial of 1,509 patients with nonmetastatic castration-resistant prostate cancer. Patients were randomly assigned 2:1 to receive either 600 mg of oral darolutamide twice daily (n = 955) or placebo (n = 554). All patients received a gonadotropin-releasing hormone analog concurrently or had had a previous bilateral orchiectomy. Twelve patients with a previous seizure history were treated on the darolutamide arm.

The primary endpoint was metastasis-free survival, which was defined as the time from randomization to first evidence of distant metastasis, or death from any cause within 33 weeks after the last evaluable scan—whichever occurred first.

The median metastasis-free survival was 40.4 months (95% confidence interval [CI] = 34.3 months to not reached) for patients treated with darolutamide compared with 18.4 months (95% CI = 15.5– 22.3 months) for those receiving placebo (hazard ratio = 0.41; 95% CI = 0.34–0.50, P < .0001). Overall survival data were not mature.

The most common adverse reactions (≥ 2%) in patients who received darolutamide were fatigue, pain in an extremity, and rash. Ischemic heart disease (4.3%) and heart failure (2.1%) were more common in the darolutamide arm. The seizure incidence was similar on the two arms (0.2%).

The recommended darolutamide dose is 600 mg (two 300-mg tablets) administered orally twice daily with food. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy.


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