Xtandi(enzalutamide)

Xtandi (enzalutamide) is indicated for the treatment of adult men with metastatic castration-resistant prostate cancer who have received docetaxel therapy. The Marketing Authorisation Application was submitted on 26 June 2012, following Scientific Advice from the CHMP on 24 June 2010 and follow-up advice on 20 January 2011.

In efficacy studies, Xtandi demonstrated a 61% reduction in rPFS event reduction (Hazard Ratio 0.39, 95% CI 0.3, 0.5) compared to placebo, where median rPFS for placebo was 19.0 months. The median rPFS for Xtandi was not reached. A significant PSA Response Rate (50% Decrease) of 54.0% was observed, compared to 1.5% for placebo (p-value <0.0001). For PSA Response Rate (90% Decrease), Xtandi showed 24.8% compared to 0.9% for placebo (p-value <0.0001). The OS Hazard Ratio was 0.81 (95% CI 0.53, 1.25) with a p-value of 0.3361.

Regarding safety, Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) were observed at rates of 24.3%, 25.6%, and 43.2% in different assessments. The median time to first grade ≥ 3 TEAE was 24.9 months and 17.7 months in separate analyses. Seizure incidence in the MDV3100 arm was 0.8%, while in the placebo arm it was 0.0%. Hypertension in the placebo arm was 2.8%.