TOKYO - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., 'Astellas') announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending an additional indication for the oral once-daily therapy XTANDITM for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC).1
Men diagnosed with mHSPC tend to have a poor prognosis, with a median survival of approximately 3-4 years, underscoring the need for new treatment options.2
If approved by the European Commission (EC), enzalutamide will be 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.3 The CHMP decision is based on data from the pivotal Phase 3 ARCHES trial investigating enzalutamide in men with mHSPC.4
'This positive opinion from the CHMP is testament to our continuing commitment to addressing unmet needs for men with advanced prostate cancer,' said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas. 'We are excited to be another step closer to approval of enzalutamide for the treatment of men with metastatic hormone-sensitive prostate cancer in Europe.'
Data from the ARCHES trial showed that 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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