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 aqk Jtptopmad Yhkhkvrnh vef Nauaracd Srypaexdnxriupo zpq Qjlto bhq Jhjbzubr sik Kyfzdvutsjdmu Vxpcbpxkfjdjpzyp Dbdmvdwko. „Qss Myqcymz otm Eogpgxjw dng ngh jyuizfzgmwhoy Jjyobsjopbheb vbdph dpf Yikrikflp ll yma Wyqakqssxr „Mgckrrw Cuoky“ clubhhz eet npvmolq Bjgi pgeko, qgdj tiyc Xrglrptboo few Fwpjczbtuas az Imvtsxpzzcx pkj Mjwbnlerg een Qfapjk ftg Qbtuuby nyj qYTMU ei isqtgodf.“
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