FDA Approves Erleada for Patients With Metastatic Castration-Sensitive Prostate Cancer

A phase 3 trial showed a 33% reduction in the risk of death when patients were treated with Erleada compared with placebo.

The Food and Drug Administration has approved Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer.

This approval is based on findings from a phase 3 clinical trial that found when patients were given Erleada plus androgen deprivation therapy (ADT), there was a 33% reduction in the risk of death compared with placebo and ADT in the same patient population.

The TITAN trial included 1,052 patients who were newly diagnosed with metastatic castration-sensitive prostate cancer and had prior therapy with docetaxel or localized treatment.

In addition to the reduction in death, researchers also saw a two-year overall survival rate of 82.4% in the group that received Erleada compared with 73.5% in patients receiving ADT alone at 22.7 months follow-up.

Side effects included rash, fatigue, fall, fracture and seizure.

Check back later to learn more about how this approval will directly impact patients with metastatic disease.