TOKYO - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., 'Astellas') announced that 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). Men diagnosed with mHSPC tend to have a poor prognosis, with a median survival of approximately 3-4 years,1 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.2 The EC approval is based on results from the pivotal Phase 3 ARCHES trial which evaluated enzalutamide in men with mHSPC.3
'Metastatic hormone-sensitive prostate cancer patients have limited options and, unfortunately, there is a poor prognosis for many men,' said Andrew Armstrong, M.D., Professor of Medicine, Surgery, Pharmacology and Cancer Biology, Director of Research in the Duke Cancer Institute's Center for Prostate and Urologic Cancers and lead investigator of ARCHES. 'The research supporting this approval provides clinical evidence showing how enzalutamide can help improve outcomes for men with mHSPC, which gives healthcare professionals in Europe the option to offer the treatment across the advanced prostate cancer disease continuum.'
Data from the ARCHES trial showed enzalutamide plus androgen deprivation therapy (ADT) 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 (CI): 0.30-0.50]; P
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