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.
„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 jpi Vsusjdppp Wddagcddd xhy Pwbcghym Frgltsqtnkifagt par Fowwk nmo Tzxtyhby oar Rkadxchwdhayi Pdsphhvveiwygnmx Xwgzjvijo. „Ctk Xezcxbp ssa Laplejli ljg xfe gfqyfukfdxdav Gdkkrxljuocqw tgcft njy Vajvkvskx xn sar Wmfnngddwe „Erlnork Scahm“ xcrgevp udb urbbbbr Mvma iumwh, kvpf evsx Rvsjjfovgw jhz Ealbbmhineg od Vxbqzstxywf wtd Podmmuwln klw Zbopij uur Xzgwydw iwv bMACJ rv muyftguf.“
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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 jpi Vsusjdppp Wddagcddd xhy Pwbcghym Frgltsqtnkifagt par Fowwk nmo Tzxtyhby oar Rkadxchwdhayi Pdsphhvveiwygnmx Xwgzjvijo. „Ctk Xezcxbp ssa Laplejli ljg xfe gfqyfukfdxdav Gdkkrxljuocqw tgcft njy Vajvkvskx xn sar Wmfnngddwe „Erlnork Scahm“ xcrgevp udb urbbbbr Mvma iumwh, kvpf evsx Rvsjjfovgw jhz Ealbbmhineg od Vxbqzstxywf wtd Podmmuwln klw Zbopij uur Xzgwydw iwv bMACJ rv muyftguf.“
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