EC approval for Xtandi in mHS prostate cancer
The European Commission (EC) 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), says Japanese drug major Astellas Pharma (TYO: 4503).
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.
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 (CRPC) and mHSPC. The EC approval is based on results from the pivotal Phase III ARCHES trial which evaluated enzalutamide in men with mHSPC.
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