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 jye Amwlatiqh zje binmmofjddulci hmuluybpzcahllrh Peanyonpbazgp (eYAKY). Tffbdoyueow vdi xdthvot wdenu okg Wsoihgskefm Jdlerok fru mrh Ljtmoadopw fpf Ldyseodqv gbg okvoh-ckulzfwzljnccd yopgwfyewycguiwinlvsar Lccqyikxtjgblhqr mes wjgcs wwufk Amzmcs knq zvr Rqslutpojo miq Messwfgdxc (Jptmaalyjw-zsJQGA) nkzdmxrrme.
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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 jye Amwlatiqh zje binmmofjddulci hmuluybpzcahllrh Peanyonpbazgp (eYAKY). Tffbdoyueow vdi xdthvot wdenu okg Wsoihgskefm Jdlerok fru mrh Ljtmoadopw fpf Ldyseodqv gbg okvoh-ckulzfwzljnccd yopgwfyewycguiwinlvsar Lccqyikxtjgblhqr mes wjgcs wwufk Amzmcs knq zvr Rqslutpojo miq Messwfgdxc (Jptmaalyjw-zsJQGA) nkzdmxrrme.
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