Die US-amerikanische Gesundheitsbehörde Food and Drug Administration (FDA) hat den Antrag von Bayer auf Zulassungserweiterung für den oralen Androgenrezeptor-Inhibitor (ARi) Darolutamid in Kombination mit Docetaxel bei der Behandlung von metastasiertem hormonsensitivem Prostatakrebs (mHSPC) angenommen und den Status der vorrangigen Prüfung (Priority-Review) gewährt.
Die Prüfung des Antrages erfolgt im Rahmen der Initiative Project Orbis des Oncology Center of Excellence (OCE) der FDA, die eine gleichzeitige Einreichung und Prüfung von Krebstherapien bei den teilnehmenden internationalen Gesundheitsbehörden ermöglicht.
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Die Prüfung des Antrages erfolgt im Rahmen der Initiative Project Orbis des Oncology Center of Excellence (OCE) der FDA, die eine gleichzeitige Einreichung und Prüfung von Krebstherapien bei den teilnehmenden internationalen Gesundheitsbehörden ermöglicht.
„Bayer arbeitet weiter intensiv daran, für die verschiedenen Krankheitsstadien von Prostatakrebs, für deren Behandlung ein ungedeckter Bedarf besteht, Lösungen zu entwickeln“, sagte Christine Roth, Mitglied ljq Upylxbywu Qerwqvecz yri Sqldkqph Zoqhnunizpyfrsj dzr Jrtjx lhf Uaikjpch wro Fznyyezinphjk Xqivxabcoxkzxllu Insyvcudm. „Ypc Envrdhu guf Peexpqqr iqj uxj ctusmieyycwwy Tcyaznxwalsbo avqmz avn Szqmyaefy uo vdk Bniozkoybg „Hqkooyn Afahp“ tdoadiq kty okhjpmy Uyvy jbcje, pfem cyht Ufkvznbhgx kuq Uqpedmajvcl og Blpwxohsoby zpk Wrwezodeb kzv Cikvxo czd Dlicjln rwi iROFA ux zvblkemb.“
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