Die US-amerikanische Zulassungsbehörde FDA (Food and Drug Administration) hat den Zulassungsantrag für den Entwicklungskandidaten Darolutamid zur Behandlung von nicht-metastasiertem kastrationsresistentem Prostatakrebs (nmCRPC) angenommen und den Status der vorrangigen Prüfung („Priority Review“) gewährt. Der Zulassungsantrag basiert auf Daten der Phase-III-Studie ARAMIS bei Männern mit nmCRPC.(1) Darolutamid ist ein experimenteller nicht-steroidaler Androgenrezeptor-Antagonist mit spezifischer chemischer Struktur, der mit hoher Affinität an den Rezeptor bindet und das Wachstum von Prostatakrebszellen hemmt.
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