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Bayer beantragt in China die Zulassung für die dritte Indikation von Darolutamid

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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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The publisher indicated in each case (see company info by clicking on image/title or company info in the right-hand column) is solely responsible for the stories above, the event or job offer shown and for the image and audio material displayed. As a rule, the publisher is also the author of the texts and the attached image, audio and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.