Xtandi Now Indicated for Nonmetastatic Castration-Resistant Prostate Cancer

October 2018, Vol 8, No 10 - FDA Approvals, News & Updates


On July 13, 2018, the FDA approved a new indication for enzalutamide (Xtandi; Astellas) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC). Enzalutamide was initially approved for metastatic CRPC in 2012.

This approval of enzalutamide for nonmetastatic CRPC was based on the randomized, multicenter, PROSPER clinical trial of 1401 patients who were randomized to enzalutamide 160 mg daily or to placebo.

Metastasis-free survival was the primary end point. The mean metastasis-free survival for patients who received enzalutamide was 36.6 months versus 14.7 months for those who received placebo (hazard ratio, 0.29; P <.0001).

The most common (≥10%) adverse reactions with enzalutamide in this study were fatigue or asthenia, hot flushes, hypertension, dizziness, nausea, and falls.