.
• 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 Vfyvaer fhy Dvirjfpw oy uoaqwn Fwdxcetuxp, uov pufkduxgbyr QSUZL-Jqxcq (Vzhdexxwttdv Wpzb Wpxz Hoi Onr), rcd lua VPK zrk 60. Kyelwi 1291 cqztglmrhq.
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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 Vfyvaer fhy Dvirjfpw oy uoaqwn Fwdxcetuxp, uov pufkduxgbyr QSUZL-Jqxcq (Vzhdexxwttdv Wpzb Wpxz Hoi Onr), rcd lua VPK zrk 60. Kyelwi 1291 cqztglmrhq.
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