Darolutamide Received FDA Approval for Treating Nonmetastatic Castration-Resistant Prostate Cancer

On 30 July 2019, the US Food and Drug Administration (FDA), for non- metastatic castration-resistant disease (resistant to suppression of male hormones), for prostate cancer treatment approved the drug darolutamide (Nubeqa).

The approval was based on a multicenter, double-blind study in 1.509 patients with nonmetastatic castration-resistant prostate cancer, placebo controlled, called ARAMIS. Patients were randomized to receive orally (by mouth) 600 mg darolutamide (955 people) or placebo (554 people), in a 2 to 1 ratio. All patients concurrently received a gonadotropin-releasing hormone (GnRH) analogue or had previously undergone bilateral orchiectomy (surgical castration). Patients with a prior history of epileptic seizures, totaling 12, were assigned to the darolutamide arm.

The study's primary endpoint was defined as the time until first distant metastasis or death from any cause, metastasis-free survival.

For patients treated with darolutamide, median metastasis-free survival was 40.4 months, compared with 18.4 months for patients receiving placebo, and darolotamide use reduced the risk of metastasis or death by %59. Overall survival data were not yet mature.

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The most common adverse effects (≥2%) in patients receiving darolutamide were fatigue, pain in the extremities (arms and legs) and rash. Ischemic heart disease (% 4.3) and heart failure (% 2.1) were more common in the darolutamide arm. The frequency of epileptic seizures was similar in both arms (% 0,2).

The recommended darolutamide dose is 600 mg given orally twice daily with food (two 300 mg tablets). Patients should also receive a gonadotropin-releasing hormone (GnRH) analogue or have undergone bilateral orchiectomy.