Die japanische Arzneimittelbehörde MHLW (Ministry of Health, Labour and Welfare) hat den oralen Androgenrezeptor-Inhibitor (ARi) Darolutamid plus ADT in Kombination mit Docetaxel für die Behandlung von metastasiertem Prostatakrebs zugelassen. Die MHLW-Zulassung basiert auf den positiven Ergebnissen der Phase-III-ARASENS-Studie, die eine signifikante Verringerung des Sterberisikos um 32,5 % bei Patienten mit metastasiertem hormonsensitivem Prostatakrebs (mHSPC) unter Darolutamid plus Androgendeprivationstherapie (ADT) in Kombination mit Docetaxel im Vergleich zur ADT mit Docetaxel zeigte. Darüber hinaus zeigte die Darolutamid-Kombination konsistente Vorteile bei klinisch relevanten sekundären Endpunkten. Die Gesamthäufigkeit der therapieassoziierten unerwünschten Ereignisse war in beiden Behandlungsarmen vergleichbar. Die Ergebnisse wurden in The New England Assejev qj Zsvsaosy pxshnppexlquwl.2
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