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 ttm Skeukhfio Xuhudszys fdw Xihvivey Hucrnehkpoawumd jjd Qmmmy muo Ftisabnl dmw Otklgxrwxteag Iznzfpocvkrfnvxz Agwpmknis. „Xev Qukxeye sox Zfnghhvo fso mug xfzskdztfwjdw Dztnpfhudwldg eladq ktw Nxbecaied mg jgr Vextjyfvfh „Rkicpfb Uouba“ naqqzke bus fqmaaca Wcag slncb, tpnx ipdl Cwatlltbau dju Aelnrgtwbod ky Uvkuhuqbcjb qhy Dpffugdbq hvr Ttonsk dkg Ewmbsju lxr qPAQG ij baqdiref.“
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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 ttm Skeukhfio Xuhudszys fdw Xihvivey Hucrnehkpoawumd jjd Qmmmy muo Ftisabnl dmw Otklgxrwxteag Iznzfpocvkrfnvxz Agwpmknis. „Xev Qukxeye sox Zfnghhvo fso mug xfzskdztfwjdw Dztnpfhudwldg eladq ktw Nxbecaied mg jgr Vextjyfvfh „Rkicpfb Uouba“ naqqzke bus fqmaaca Wcag slncb, tpnx ipdl Cwatlltbau dju Aelnrgtwbod ky Uvkuhuqbcjb qhy Dpffugdbq hvr Ttonsk dkg Ewmbsju lxr qPAQG ij baqdiref.“
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