Die 4SC AG (4SC, FSE Prime Standard: VSC), ein Biotech-Unternehmen, das das Leben von Patienten mit kutanem T-Zell-Lymphom (CTCL) im fortgeschrittenen Stadium verbessert, hat heute bekannt gegeben, dass sie den Antrag auf Marktzulassung (MAA) für Resminostat (Kinselby) bei der Europäischen Arzneimittelagentur (EMA) eingereicht hat und dass dieser Antrag von der EMA für die Prüfung akzeptiert wurde.
Im September 2023 gab das Unternehmen Daten aus seiner RESMAIN-Studie zu Resminostat (Kinselby) bekannt. Diese die zeigten:
Eine statistisch signifikante Verbesserung des progressionsfreien Überlebens (medianes PFS: 8,3 vs. 4,2 Monate; p=0,015; HR: 0,623)
Eine signifikante Verbesserung der medianen Zeit bis zur nächsten Behandlung im Vergleich
Im September 2023 gab das Unternehmen Daten aus seiner RESMAIN-Studie zu Resminostat (Kinselby) bekannt. Diese die zeigten:
Eine statistisch signifikante Verbesserung des progressionsfreien Überlebens (medianes PFS: 8,3 vs. 4,2 Monate; p=0,015; HR: 0,623)
Eine signifikante Verbesserung der medianen Zeit bis zur nächsten Behandlung im Vergleich
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