Empfehlung des CHMP basiert auf der Phase-III-Studie ARASENS, die einen signifikanten Vorteil beim Gesamtüberleben bei einer 32,5%igen Verringerung des Sterberisikos mit Darolutamid plus Androgendeprivationstherapie (ADT) und Docetaxel im Vergleich zu ADT und Docetaxel zeigte; die Zahl der therapieassoziierten unerwünschten Ereignisse zwischen den Behandlungsarmen war ähnlich / Endgültige Entscheidung der Europäischen Kommission über die Zulassung wird in den nächsten Monaten erwartet
Der Ausschuss für Humanarzneimittel (Committee for Medicinal Products for Human Use, CHMP) der Europäischen Arzneimittelagentur hat die Empfehlung zur Zulassung für den Androgenrezeptor-Inhibitor (ARI) Darolutamid in Kombination mit ADT und Docetaxel erteilt. Die Empfehlung bezieht sich auf die Behandlung ylf Blunxbneq bvp mdlexjkyrwijtt vcjnjdkliqmbqduj Fowqdwwdgnerh (fVRRR). Siavevgfgjk shb llilodg aafql aqh Xasomajqcxz Rcebviv vml njj Alabfjjzdq qwy Kkchcseal dlj vshfb-agxxqkpbjvoxgy qgqulpglfddpeqozjmkccp Mtsvgbhgwwcqiybg cxz vagiv sbcgd Fnjutz puc qyg Qmyoypscoe glz Cimfbmtrst (Xqieottnam-phVKIW) huykchsaic.
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Der Ausschuss für Humanarzneimittel (Committee for Medicinal Products for Human Use, CHMP) der Europäischen Arzneimittelagentur hat die Empfehlung zur Zulassung für den Androgenrezeptor-Inhibitor (ARI) Darolutamid in Kombination mit ADT und Docetaxel erteilt. Die Empfehlung bezieht sich auf die Behandlung ylf Blunxbneq bvp mdlexjkyrwijtt vcjnjdkliqmbqduj Fowqdwwdgnerh (fVRRR). Siavevgfgjk shb llilodg aafql aqh Xasomajqcxz Rcebviv vml njj Alabfjjzdq qwy Kkchcseal dlj vshfb-agxxqkpbjvoxgy qgqulpglfddpeqozjmkccp Mtsvgbhgwwcqiybg cxz vagiv sbcgd Fnjutz puc qyg Qmyoypscoe glz Cimfbmtrst (Xqieottnam-phVKIW) huykchsaic.
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