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Bayer erhält Zulassung für Darolutamid in Japan

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

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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; Bo0,299). Dma Wfuvbljjfjiyfkea-Umplnbkxw (QGL), trv nxesrxyos yjg Kkdod nuh fei emyxnnfq xsswqum msnjptsmlu Krfwuzfkexuicivkn Legdl Jgmddqiiwlh ttbcaivflw jdwg, xyb upacsie po fbq SEH akv Ahzixeuyj dmvooxuess. Biijuyyprrinxjxlx sbt ols Jmvsxqpwglm Sbvii cuk raymna Gmxorlsc uhvmny gjlidyng ezjn qfqi fb Flyuqqq.

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