Antrag basiert auf positiven Ergebnissen der pivotalen Phase-III-Studie ARANOTE, die zeigte, dass Darolutamid plus Androgendeprivationstherapie (ADT) bei Patienten mit metastasiertem hormonsensitivem Prostatakrebs (mHSPC) im Vergleich zu Placebo plus ADT das radiologische Progressions- oder Sterberisiko signifikant um 46% reduzierte
Für Darolutamid plus ADT liegen nun positive Daten aus zwei pivotalen Phase-III-Studien bei Patienten mit mHSPC vor, sowohl in Kombination mit als auch ohne Docetaxel
Bayer hat beim Center of Drug Evaluation (CDE) der Nationalen Arzneimittelbehörde Chinas (NMPA) einen Zulassungsantrag für den oralen Androgenrezeptor-Inhibitor (ARi) Darolutamid eingereicht. Bayer beantragt die Zulassung von Darolutamid in Kombination mit einer Androgendeprivationstherapie (ADT) bei Patienten mit metastasiertem
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ljip Rcolahfeeuo (Efmmilz)
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