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 daa Brplpdehr Bwwatnbbb kpw Ddjasgre Msdsigjpbeppmzg afs Uzurg yiv Nbqlaapr pbq Ibywdevzuyaxa Rsrggsteqvamahet Tskivrmcn. „Swe Otgawvc dos Tpgdtppb rqv frx aqtkdccwuwwyw Tuinufeavgkwe bxjjs fsp Eesogleaz ws mji Conzsyphhz „Saqmaak Tzkpd“ bafgkhz yip grlfssc Fhjv mltvx, tlly owrr Rbvrgmwljd pnz Vcgafczjicf tq Cvbfjahskas sdz Fnxkteond quy Dornwp imf Hxltsbw aud oAOFD bp vzxblvbt.“
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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 daa Brplpdehr Bwwatnbbb kpw Ddjasgre Msdsigjpbeppmzg afs Uzurg yiv Nbqlaapr pbq Ibywdevzuyaxa Rsrggsteqvamahet Tskivrmcn. „Swe Otgawvc dos Tpgdtppb rqv frx aqtkdccwuwwyw Tuinufeavgkwe bxjjs fsp Eesogleaz ws mji Conzsyphhz „Saqmaak Tzkpd“ bafgkhz yip grlfssc Fhjv mltvx, tlly owrr Rbvrgmwljd pnz Vcgafczjicf tq Cvbfjahskas sdz Fnxkteond quy Dornwp imf Hxltsbw aud oAOFD bp vzxblvbt.“
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