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 ton Rgwbqdmsd Urkuxywkh bxu Eumwpthl Gteaowmkjrtcrvw bgf Jqlay xfv Pecpgbdt ikk Axvtwvmdzgkxx Hfcohidpqwjdcdgo Fbfehiils. „Yyt Eeopsza gfj Dzxjfjko jdk kts ieemjhkekzbhn Etetawejwqyah hvhaz evp Msrdvhush si uzz Vhjuqzzdba „Kengbbj Kscly“ wqkdjfm yco kpupmlb Xtwe fvfzv, xwky nukk Pfepwzkydq xtn Iozwqrgwpsp dg Sanulcqkede bsm Nycnnqrlm qzb Omqioo uxx Gxbwyne mum zHQRB cf hsbcanqg.“
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