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FDA Approves Darolutamide for Nonmetastatic CRPC
The FDA has approved darolutamide (Nubeqa; Bayer HealthCare Pharmaceuticals) for the treatment of patients with nonmetastatic, castration-resistant prostate cancer (CRPC). The drug was granted fast track designation and priority review by the FDA.
This approval was based on the multi-center, double-blind, placebo-controlled ARAMIS clinical trial, which included 1509 patients with nonmetastatic CRPC randomized in a 2:1 ratio to receive darolutamide 600 mg twice daily (n = 955) or matching placebo (n = 554).
All patients were concurrently given a gonadotropin-releasing hormone (GnRH) analog or underwent a previous bilateral orchiectomy. Of note, there were 12 patients with a history of seizures treated with darolutamide.
The primary end point of the study was metastasis-free survival (MFS; ie, time from randomization to first evidence of distant metastasis or death from any cause within 33 weeks of the last evaluable scan).
Results showed a median MFS of 40.4 months (95% CI, 34.3 to not reached) and 18.4 months (95% CI, 15.5-22.3) for patients in the darolutamide and placebo arms, respectively (hazard ratio, 0.41; 95% CI, 0.34-0.50; P <.0001). The data regarding OS were not mature.
The most common (≥2%) adverse events associated with darolutamide use were fatigue, pain in extremity, and rash; although ischemic heart disease (4.3%) and heart failure (2.1%) occurred more frequently with darolutamide, the seizure incidence rate was similar between both treatment arms (0.2%).—Hina Khaliq
Source: US Food and Drug Administration. FDA approves darolutamide for non-metastatic castration-resistant prostate cancer. Updated July 31, 2019. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-non-metastatic-castration-resistant-prostate-cancer. Accessed July 31, 2019.
