Darolutamide (Nubeqa)—a new androgen-receptor inhibitor—was approved in 2019 by the U.S. Food and Drug Administration to treat men with prostate cancer that has not spread beyond the prostate to other parts of the body, but no longer responds to androgen-deprivation therapy (nonmetastatic castration-resistant prostate cancer; CRPC). Darolutamide joins two other drugs in this class, apalutamide (Erleada) and enzalutamide (Xtandi).
Darolutamide’s approval was based on results from a double-blind, placebo-controlled clinical trial involving 1,509 men with nonmetastatic CRPC. For the study, 955 men were treated with darolutamide (600 mg twice daily) and 554 received a placebo. All patients received medical or surgical treatment to lower testosterone. The study results, which were published in 2019 in The New England Journal of Medicine, showed that the median metastasis-free survival time was 40 months for men treated with darolutamide compared with 18 months for those receiving placebo.
The most common adverse reactions in treated patients were fatigue; pain in the arm, hand, foot, or leg; rash; lowered white blood cell counts (neutropenia); and changes in liver function tests. Serious adverse events occurred in 25 percent of men in the darolutamide group and 20 percent in the placebo group. The recommended dosage for darolutamide is 600 mg (taken as two 300 mg tablets) twice daily with food.