Darolutamide tablets is approved by FDA for metastatic hormone-sensitive prostate cancer

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August 2022: Darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) tablets combined with docetaxel were approved by the Food and Drug Administration for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).

ARASENS (NCT02799602), a randomised, multicenter, double-blind, placebo-controlled clinical trial involving 1306 patients with mHSPC, served as the foundation for the effectiveness. Patients were randomly assigned to receive either docetaxel plus placebo or darolutamide 600 mg orally twice daily in addition to docetaxel 75 mg/m2 intravenously given every three weeks for up to six cycles. All patients had bilateral orchiectomy or concurrent administration of a gonadotropin-releasing hormone analogue.

The overall survival rate was the main efficacy metric (OS). Another metric for efficacy was the time until pain began to progress. In the darolutamide plus docetaxel arm, the median OS was not attained (NR) (95% CI: NR, NR), whereas in the docetaxel plus placebo arm, the median OS was 48.9 months (95% CI: 44.4, NR) (HR 0.68; 95% CI: 0.57, 0.80; p0.0001). Time to pain progression was statistically significantly delayed by treatment with darolutamide plus docetaxel (HR 0.79; 95% CI: 0.66, 0.95; 1-sided p=0.006).

The patients’ average age ranged from 41 to 89, and 17% of them were 75 or older. The following list of selected demographics was provided: 36% Asian, 4% Black or African American, 52% White, 7% Hispanic/Latino. Patients who had M1a disease (3%) had it spread to distant lymph nodes, 83% had M1b disease (83%), and 14% had M1c disease (spread to organs).

Constipation, a decrease in appetite, a rash, bleeding, a rise in weight, and hypertension were the most frequent adverse effects reported by patients (incidence 10% with a 2% increase above placebo with docetaxel). Anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, elevated ALT, and hypocalcemia were the most prevalent abnormalities seen in laboratory tests (30%).

For mHSPC, a dose of 600 mg (two 300 mg tablets) of darolutamide twice daily with food is advised until intolerable toxicity or disease progression. For up to 6 cycles, docetaxel 75 mg/m2 is intravenously injected every 3 weeks. Within six weeks after the initiation of the darolutamide treatment, the first dosage of docetaxel should be given.

View full prescribing information for Nubeqa.

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