The FDA approved darolutamide for treatment of men with nonmetastatic castration-resistant prostate cancer.
The agency had granted priority review to darolutamide (Nubeqa, Bayer) — an androgen receptor inhibitor — for this indication and issued its approval 3 months ahead of the target action date.
The FDA based the approval on results of the randomized phase 3 ARAMIS trial, which included 1,509 men with nonmetastatic castration-resistant prostate cancer who were receiving a concomitant gonadotropin-releasing hormone analog or had a bilateral orchiectomy.
Researchers assigned trial participants 2:1 to androgen deprivation therapy plus either 600 mg oral darolutamide twice daily or placebo.
Metastasis-free survival served as the primary endpoint.
Results of the double-blind, multicenter trial showed men assigned ADT plus darolutamide achieved significantly longer metastasis-free survival (40.4 months vs. 18.4 months; HR = 0.41; 95% CI, 0.34-0.5).
OS served as a secondary efficacy endpoint, but data were not mature at the time of final metastasis-free survival analysis.
Nine percent of men in each treatment group discontinued therapy due to adverse reactions. The most common adverse reactions that prompted discontinuation by men assigned darolutamide included cardiac failure (0.4%) and death (0.4%).
Adverse reactions that occurred more frequently in the darolutamide group than the placebo group included fatigue (16% vs. 11%), extremity pain (6% vs. 3%) and rash (3% vs. 1%).
Approximately one-third of men with nonmetastatic castration-resistant prostate cancer develop metastases within 2 years.
“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 of the genitourinary malignancies program at Massachusetts General Hospital Cancer Center, said in a press release. “This approval marks an important new option for the prostate cancer community.”