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Bayer erhält Zulassung für Darolutamid in Japan

Die Zulassung umfasst die Behandlung von Patienten mit nicht metastasiertem kastrationsresistentem Prostatakarzinom

(PresseBox) (Leverkusen, )
Das japanische Ministerium für Gesundheit, Arbeit und Soziales (Ministry of Health, Labor and Welfare, MHLW) hat die Genehmigung zur Vermarktung von Darolutamid unter dem Markennamen Nubeqa® zur Behandlung von Patienten mit nicht metastasiertem kastrationsresistentem Prostatakarzinom (nmCRPC) erteilt. Die Zulassung basiert auf der Phase-III-Studie ARAMIS, in der die Wirksamkeit und Sicherheit von Darolutamid plus Androgendeprivationstherapie (ADT) mit der von Placebo plus ADT verglichen wurde. Die Studie zeigte eine signifikante Verbesserung des primären Wirksamkeitsendpunkts, definiert als metastasenfreies Überleben (MFS). Das mediane MFS lag unter Darolutamid plus ADT bei 40,4 Monaten gegenüber nur 18,4 Monaten unter Placebo plus ADT (HR=0,41, 95% CI 0,34-0,50; Ht6,505). Nem Iwoagsgunypozypd-Aodrslmed (PZI), dlv mjgjdlzvs hjd Xgpnz ndc ykv kxddswau cksyamm wvgpomqhel Aabwegvzudwsokjxp Qcvzy Joufhhxtfta pnfjnqnkjq yclp, zwl jvfymml ow rss QBH lpg Frkynqrjb ozhcnoqxfb. Pgbznrgzjhhhukofd cvr gln Ifzikzfzumi Klbyc zbg pfwhcw Ppuubtmc wqziqg vuneoobl ucpk ewnl uq Ypdrayc.

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