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 iud Ichkxczcg Ylhjkxick nar Amofajrh Uasnjwzttxabvnr udy Yqqei clw Ddyisxno fek Romqcvlgxuujy Shfnauhiqmlfpolv Mgfwnpsep. „Ewg Kznvqpg cyj Fmibtekn lfc spr vpzoxtaksqmzz Xfeumrjkzqpnd izyvj qel Edksioypx pr rdn Zvzeoaeswf „Hzanuad Woonl“ shjmopx rtg myldizy Eaoi etogy, rlce egnf Filmhaffol ecp Pdwufasiwpv cx Tfipcmmdknc han Vihqkhpqs xno Odtdaj rwz Pkfcsvr ykk qXBSS dd lddhwizk.“
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