Enzalutamide (Xtandi) approved by European Commission for men with metastatic hormone-sensitive prostate cancer
Approval is based on results from the pivotal Phase 3 ARCHES trial (n=1150) which showed enzalutamide significantly reduced the risk of radiographic progression or death by 61% vs placebo plus androgen deprivation therapy (HR=0.39 [95% CI 0.30-0.50] P<0.0001)
Source:
Biospace Inc.