Nubeqa New Oral Therapy FDA Approved for Nonmetastatic Prostate Cancer

Web Exclusives - FDA Updates

On July 30, 2019, the FDA approved darolutamide (Nubeqa; Bayer HealthCare), an oral androgen receptor inhibitor, for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC). This approval was based on a multicenter, double-blind, placebo-controlled clinical trial known as ARAMIS. The FDA granted this application priority review.

“Patients at this stage of prostate cancer typically don’t have symptoms of the disease. The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy,” Matthew Smith, MD, PhD, Director, Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center, said in a statement.

The study included 1509 patients with nonmetastatic CRPC who were randomized in a 2:1 ratio to darolu­tamide or to placebo. In addition, all patients received a gonadotropin-releasing hormone analog unless they previously had a bilateral orchiectomy.

The primary end point was metastasis-free survival. The median metastasis-free survival was 40.4 months (95% confidence interval [CI], 34.3 months-not reached) with darolutamide versus 18.4 months (95% CI, 15.5-22.3 months) with placebo (hazard ratio, 0.41; 95% CI, 0.34-0.50; P <.0001). The overall survival data were not yet mature at the FDA approval.

The most common (≥2%) adverse events with darolutamide were fatigue, extremity pain, and rash. Ischemic heart disease (4.3%) and heart failure (2.1%) were more common with darolutamide than with placebo.

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Last modified: July 22, 2021