FDA Expands Approval for Erleada® in Prostate Cancer

The U.S. Food and Drug Administration expanded the approval of Erleada® (apalutamide) to include the treatment of men with metastatic castration-sensitive prostate cancer. The oral androgen receptor inhibitor was previously approved to treat non-metastatic castration-resistant prostate cancer.

The decision was based on results of the randomized, placebo-controlled, double-blind, phase III TITAN study that was published in The New England Journal of Medicine. The study included 1,052 patients with metastatic castration-sensitive prostate cancer from 23 countries in North America, Latin America, South America, Europe, and the Asia-Pacific region.

Improved survival with addition of apalutamide

Patients were randomized to receive androgen deprivation therapy (ADT) plus apalutamide 240 mg daily (n=524) or placebo (n=527). The addition of apalutamide to ADT significantly extended overall survival (OS; hazard ratio [HR] = 0.67; 95% CI, 0.51-0.89) and radiographic progression-free survival (HR=0.48; 95% CI, 0.39-0.6), both of which were primary endpoints.

After a median follow-up of 22.7 months, two-year OS rates were 84% for ADT plus apalutamide and 78% for ADT plus placebo.

The most common adverse events (AEs) associated with apalutamide included fatigue, arthralgia, rash, decreased appetite, falls, weight loss, hypertension, hot flushes, diarrhea, and fractures. The frequency of grade 3/4 AEs was 42.2% in the apalutamide group and 40.8% in the placebo group.