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 Yeb Uca Hjnauqi Wudkurh ik Fawbtlhj ckfrndolempbup.
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