Antrag auf Zulassung für Indikation bei Patienten mit metastasiertem hormonsensitivem Prostatakrebs (mHSPC) gestellt / Einreichung basiert auf Daten aus der zulassungsrelevanten Phase-III-Studie ARASENS, die kürzlich im New England Journal of Medicine veröffentlicht wurden / Ergebnisse zeigen, dass die Anwendung von Darolutamid plus Androgendeprivationstherapie (ADT) und Docetaxel zu einer statistisch signifikanten Verbesserung des Gesamtüberlebens (OS) im Vergleich zu ADT plus Docetaxel sowie zu konsistenten Verbesserungen von wichtigen sekundären Endpunkten bei Patienten mit mHSPC führte, mit ähnlichen Gesamtzahlen unerwünschter Ereignisse (AEs) zwischen den Studienarmen / Weltweit laufen weitere Einreichungen für mHSPC oder sind geplant / Umfassendes Entwicklungsprogramm mit drei weiteren laufenden oder
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