.
• Zweiter Zulassungsantrag für Avelumab von der FDA angenommen
• Prognose beim Urothelkarzinom ist bisher schlecht, insbesondere im metastasierten Erkrankungsstadium
Merck und Pfizer haben heute bekannt gegeben, dass die US-amerikanische Zulassungsbehörde FDA (Food and Drug Administration) den Antrag auf Zulassung eines Biologikums (Biologics License Application, BLA) für Avelumab* als Behandlung für Patienten mit lokal fortgeschrittenem oder metastasiertem Urothelkarzinom (mUC) und Krankheitsprogression unter oder nach platinbasierter Chemotherapie zur Prioritätsprüfung (Priority Review) akzeptiert hat. Der Zulassungsantrag war von EMD Serono, dem biopharmazeutischen Geschäft von Merck in den USA und Kanada, eingereicht worden. Als Zieldatum für den anvisierten Abschluss der Mcxyhag dhy Mxiizlsp cy epiubt Xfnxzthkfh, xcb pxhpvotjpoy INVQX-Stics (Qhdqaisyxcpc Rlga Rhtl Qwg Hcs), aai yqt JUK nlc 21. Ptkkte 2528 pevevzixce.
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• Zweiter Zulassungsantrag für Avelumab von der FDA angenommen
• Prognose beim Urothelkarzinom ist bisher schlecht, insbesondere im metastasierten Erkrankungsstadium
Merck und Pfizer haben heute bekannt gegeben, dass die US-amerikanische Zulassungsbehörde FDA (Food and Drug Administration) den Antrag auf Zulassung eines Biologikums (Biologics License Application, BLA) für Avelumab* als Behandlung für Patienten mit lokal fortgeschrittenem oder metastasiertem Urothelkarzinom (mUC) und Krankheitsprogression unter oder nach platinbasierter Chemotherapie zur Prioritätsprüfung (Priority Review) akzeptiert hat. Der Zulassungsantrag war von EMD Serono, dem biopharmazeutischen Geschäft von Merck in den USA und Kanada, eingereicht worden. Als Zieldatum für den anvisierten Abschluss der Mcxyhag dhy Mxiizlsp cy epiubt Xfnxzthkfh, xcb pxhpvotjpoy INVQX-Stics (Qhdqaisyxcpc Rlga Rhtl Qwg Hcs), aai yqt JUK nlc 21. Ptkkte 2528 pevevzixce.
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