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US-Gesundheitsbehörde FDA genehmigt die zusätzliche Anwendung von Darolutamid in Kombination mit Docetaxel bei metastasiertem hormonsensitivem Prostatakrebs (mHSPC)

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Darolutamid hat nun in den USA eine Zulassung für die Anwendung sowohl beim metastasierten hormonsensitiven Prostatakrebs als auch beim nicht-metastasierten kastrationsresistenten Prostatakrebs mit einem hohen Risiko für die Entstehung von Metastasen / Die heutige Zulassung im Rahmen des RTOR-Pilotprogramms (Real-Time Oncology Review) der FDA basiert auf der zulassungsrelevanten Phase-III-Studie ARASENS, die einen signifikanten Vorteil beim Gesamtüberleben (Overall Survival, OS) mit Darolutamid plus Androgendeprivationstherapie (ADT) und Docetaxel im Vergleich zu ADT und Docetaxel zeigte / Darolutamid ist der einzige Androgenrezeptor-Inhibitor (ARi), der in Kombination mit Docetaxel zugelassen ist, bei einer 32,5%igen Verringerung des Sterberisikos im Beobachtungszeitraum gegenüber Docetaxel allein

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