FDA Approved Erleada for Metastatic Castration-Sensitive Prostate Cancer

Web Exclusives - FDA Updates

On September 17, 2019, the FDA approved a new indication for apalu­tamide (Erleada; Janssen Biotech) for the treatment of patients with metastatic castration-sensitive prostate cancer (CSPC). Apalutamide was initially approved in 2018 for the treatment of nonmetastatic castration-resistant prostate cancer. The FDA granted apalutamide priority review for the new indication.

This new indication was approved based on results of the TITAN study, a randomized, double-blind, placebo-controlled clinical trial of 1052 patients with metastatic CSPC. Patients were randomized to apalutamide or to placebo. In addition, all patients also received androgen-deprivation therapy (ADT).

At a prespecified interim analysis, the hazard ratio (HR) for overall survival (OS) was 0.67 (95% confidence interval [CI], 0.51-0.89; P = .005); a median OS was not reached in either arm. The radiographic progression-free survival (PFS) was HR 0.48 (95% CI, 0.39-0.60; P <.0001). The median radiographic PFS was not reached in the apalutamide (plus ADT) arm versus 22.1 months in the placebo (plus ADT) arm.

The most common (≥10%) side effects with apalutamide were fatigue, arthralgia, rash, decreased appetite, fall, decreased weight, hypertension, hot flushes, diarrhea, and fracture.

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Last modified: July 22, 2021