On September 17, 2019, the Food and Drug Administration approved apalutamide (ERLEADA®), (Janssen Biotech, Inc) for men with metastatic castration-sensitive prostate cancer (mCSPC). Apalutamide was initially approved in 2018 for men with non-metastatic castration-resistant prostate cancer.

The efficacy of apalutamide was demonstrated in the TITAN trial (NCT02489318), which was a randomized, double-blind, placebo-controlled, multi-center clinical trial enrolling 1,052 men with mCSPC. In the trial, men received either apalutamide 240 mg daily or placebo, orally. All men continued to receive androgen deprivation therapy (ADT). The trial enrolled men with both high- and low-volume disease.

Statistically significant improvements in both primary efficacy outcomes of overall survival (OS) and radiographic progression-free survival (rPFS) were demonstrated in TITAN. At the time of a pre-specified interim analysis, the hazard ratio for OS was 0.67 (95% CI: 0.51, 0.89; p=0.0053); however, median OS was not reached in either arm.

The most common adverse reactions (incidence ≥10%) for men who received apalutamide were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.

The recommended dose of apalutamide is 240 mg (four 60 mg tablets) orally once daily, with or without food. Since TITAN was structured with all the subjects continuing to receive ADT the FDA approval includes the requirement that men should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy (ADT).

View full prescribing information for ERLEADA.