The European Commission has approved an additional indication for the oral once-daily therapy Xtandi (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC).
Men diagnosed with mHSPC tend to have a poor prognosis, with a median survival of approximately three to four years, underscoring the need for new treatment options.
Xtandi is sponsored by Astellas Pharma Inc.
With this indication, enzalutamide is now the only oral treatment approved by the EC to treat three distinct types of advanced prostate cancer—non-metastatic and metastatic castration resistant prostate cancer and mHSPC.
The EC approval is based on results from the pivotal phase III ARCHES trial which evaluated enzalutamide in men with mHSPC.
Data from the ARCHES trial showed enzalutamide plus androgen deprivation therapy significantly reduced the risk of radiographic progression or death by 61% versus placebo plus ADT in men with mHSPC (n=1,150; hazard ratio [HR]=0.39 [95% confidence interval: 0.30-0.50]; P<0.0001).
The safety analyses of the ARCHES trial appear consistent with the safety profile of enzalutamide in previous clinical trials in CRPC. In ARCHES, Grade 3 or greater adverse events
The EC marketing authorization for enzalutamide in men with mHSPC is applicable to European Union member countries, and is also valid in Iceland, Norway and Liechtenstein.