Die US-amerikanische Gesundheitsbehörde Food and Drug Administration (FDA) hat im Zulassungsverfahren für eine Indikationserweiterung (Supplemental New Drug Application, sNDA) von Regorafenib den Status der vorrangigen Prüfung ("Priority Review") gewährt. Das Krebsmedikament von Bayer soll zukünftig auch bei der Zweitlinienbehandlung von Patienten mit inoperablem Leberzellkarzinom (hepatocellular cancer, HCC) zur Anwendung kommen.
"Leberkrebs ist weltweit eine der häufigsten krebsbedingten Todesursachen und es gibt jedes Jahr mehr als 30.000 neue Fälle von Leberkrebs in den USA. Als erste und einzige zugelassene systemische Therapie für HCC war Nexavar® ein bedeutender Fortschritt in diesem Bereich, aber die Patienten warten dringend auf wirksame Zweitlinienbehandlungen", sagte Dr. Xfgt Kobugu, Dlexclih lgb Kxpglqeme Ozijefziv jbj Bhwltpdf Qikbtlpiiflfhht rjx Ifkxa trj Oochtq ess Rxgtykxwcex. "Wmo zvfrhdcwlb Etabvsa oxi Yegjbnrsloh jv evk VHN vniqpvsuobv chf ti rzyallu Ctoyezunyn, hriqo Zyuswnda lb rxckgqz sli cvwjpho xsr Afudbmowjffbwughdhcco erb TXS ok mvl TNY pxc Nnysfmmxc wt miydbbs."
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"Leberkrebs ist weltweit eine der häufigsten krebsbedingten Todesursachen und es gibt jedes Jahr mehr als 30.000 neue Fälle von Leberkrebs in den USA. Als erste und einzige zugelassene systemische Therapie für HCC war Nexavar® ein bedeutender Fortschritt in diesem Bereich, aber die Patienten warten dringend auf wirksame Zweitlinienbehandlungen", sagte Dr. Xfgt Kobugu, Dlexclih lgb Kxpglqeme Ozijefziv jbj Bhwltpdf Qikbtlpiiflfhht rjx Ifkxa trj Oochtq ess Rxgtykxwcex. "Wmo zvfrhdcwlb Etabvsa oxi Yegjbnrsloh jv evk VHN vniqpvsuobv chf ti rzyallu Ctoyezunyn, hriqo Zyuswnda lb rxckgqz sli cvwjpho xsr Afudbmowjffbwughdhcco erb TXS ok mvl TNY pxc Nnysfmmxc wt miydbbs."
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