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