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Bayer beantragt Zulassung für Darolutamid in den USA

(PresseBox) (Berlin, )
Bayer hat für seinen Wirkstoff Darolutamid die Einreichung der Zulassungsunterlagen (Rolling New Drug Application) bei der US-Gesundheitsbehörde FDA (Food and Drug Administration) abgeschlossen. Der Zulassungsantrag, dessen Einreichung im Dezember 2018 begann, basiert auf Daten aus der Phase-III-Studie ARAMIS bei Männern mit nicht-metastasiertem kastrationsresistentem Prostatakarzinom (nmCRPC), die eine statistisch signifikante Verlängerung des metastasenfreien Überlebens bei Behandlung mit Darolutamid in Verbindung mit einer Androgendeprivationstherapie (ADT) zeigen. Darolutamid plus ADT zeigte zudem im Vergleich zu Placebo plus ADT ein günstiges Sicherheitsprofil.(1) Diese Daten wurden beim ASCO-GU Kongress (American Society of Clinical Oncology Genitourinary Cancers Symposium) in San Francisco, USA, präsentiert und gleichzeitig in Iqq Nuy Izoakzb Pqfffbu om Fnganpae telgoduaymkcpv.

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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.