We are happy to announce that on July 30, 2019, the Food and Drug Administration (FDA) approved a new drug, darolutamide (NUBEQA®, Bayer HealthCare Pharmaceuticals Inc.) for the treatment of men with non-metastatic castration-resistant prostate cancer.
The approval was based on the clinical trial called ARAMIS (NCT02200614), a multicenter, double-blind, placebo-controlled clinical trial in 1,509 men with non-metastatic castration resistant prostate cancer.
The men were randomized (2:1) to receive either 600 mg darolutamide orally twice daily (n=955) or placebo (n=554). In addition to the darolutamide, the men received a gonadotropin-releasing hormone (GnRH) analog (like Lupron) concurrently or had a previous orchiectomy.
The trial’s primary endpoint was metastasis free survival (MFS), defined as the time from randomization to the first evidence of distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.
The median MFS was 40.4 months for men treated with darolutamide compared with 18.4 months for those receiving placebo. The overall survival (OS) data had not matured.
The most common adverse reactions (≥2%) in the men who received darolutamide were fatigue, pain in their extremities, and rash. Ischemic heart disease (4.3%) and heart failure (2.1%) were more common on the men receiving darolutamide. The seizure incidence was similar in the two arms (0.2%).
The FDA has recommended that the darolutamide dose is 600 mg (two 300 mg tablets) administered orally twice daily with food. Men should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
As usual, the FDA is urging that all serious adverse events suspected to be associated with the use of any medicine and device be reported to the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
