MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) und Incyte (NASDAQ:INCY) gaben heute bekannt, dass die Schweizerische Arzneimittelbehörde (Swissmedic) den Zulassungsantrag für Tafasitamab, einen humanisierten, Fc-modifizierten, zytolytischen, gegen CD19-gerichteten, monoklonalen Antikörper, angenommen hat. Der Antrag betrifft die Zulassung von Tafasitamab in Kombination mit Lenalidomid, gefolgt von einer Tafasitamab-Monotherapie, zur Behandlung von erwachsenen Patienten mit rezidiviertem oder refraktärem diffusen grosszelligen B-Zell-Lymphom (Diffuse Large B-Cell Lymphoma, DLBCL), einschliesslich durch niedergradiges Lymphom bedingtem DLBCL, und die nicht für eine autologe Stammzelltransplantation (autologous stem cell transplant, ASCT) in Frage kommen. Der Zulassungsantrag wird nun in den formalen Überprüfungsprozess seitens Swissmedic eintreten.
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