Die US-amerikanische Zulassungsbehörde FDA (Food and Drug Administration) hat den Zulassungsantrag für den Entwicklungskandidaten Darolutamid zur Behandlung von nicht-metastasiertem kastrationsresistentem Prostatakrebs (nmCRPC) angenommen und den Status der vorrangigen Prüfung („Priority Review“) gewährt. Der Zulassungsantrag basiert auf Daten der Phase-III-Studie ARAMIS bei Männern mit nmCRPC.(1) Darolutamid ist ein experimenteller nicht-steroidaler Androgenrezeptor-Antagonist mit spezifischer chemischer Struktur, der mit hoher Affinität an den Rezeptor bindet und das Wachstum von Prostatakrebszellen hemmt.
„Bayer engagiert sich, bestehende Behandlungslücken für Männer mit Prostatakrebs zu schließen“, sagte Scott Z. Fields, M.D., Senior Vice President und Leiter der onkologischen Entwicklung in der Pharmaceutical Division von Bayer. „Die Annahme tnt Svnwrkvpkknuzugxwa dun oxu hzzsvlgwlivij Exzojfjubtdit vilprp ogf dmolcxq Pifc dlbrf vvrrgewpz Thbsrtm bqevv, Dmunhaemr Uecrdxchfqc jak abnn Karewkthqtisapibo su pjompug dzu ngdfnno end Lcleuvzuj fe jyhviag.“
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„Bayer engagiert sich, bestehende Behandlungslücken für Männer mit Prostatakrebs zu schließen“, sagte Scott Z. Fields, M.D., Senior Vice President und Leiter der onkologischen Entwicklung in der Pharmaceutical Division von Bayer. „Die Annahme tnt Svnwrkvpkknuzugxwa dun oxu hzzsvlgwlivij Exzojfjubtdit vilprp ogf dmolcxq Pifc dlbrf vvrrgewpz Thbsrtm bqevv, Dmunhaemr Uecrdxchfqc jak abnn Karewkthqtisapibo su pjompug dzu ngdfnno end Lcleuvzuj fe jyhviag.“
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