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GPC Biotech reicht Zulassungsantrag für den führenden Krebs-Medikamentenkandidaten Satraplatin bei US-Zulassungsbehörde FDA ein

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Die GPC Biotech AG (Frankfurt: GPC; TecDAX 30; NASDAQ: GPCB) gab heute bekannt, dass das Unternehmen die schrittweise Einreichung des Zulassungsantrags (Rolling NDA) für Satraplatin in Kombination mit Prednisone zur Zweitlinien-Chemotherapie von Patienten mit hormonresistentem Prostatakrebs bei der US-Zulassungsbehörde FDA abgeschlossen hat. Das Unternehmen reichte mit der klinischen Dokumentation den dritten und damit letzten Teil des Zulassungsantrags ein. Diese Sektion setzt sich hauptsächlich aus den klinischen Daten der Phase-3-Zulassungsstudie SPARC zusammen. Die Studie rekrutierte 950 Patienten und zeigte eine statistisch hoch signifikante Verlängerung des progressionsfreien Überlebens. Die FDA wird innerhalb von 60 Tagen entscheiden, ob der Zulassungsantrag den regulatorischen Anforderungen dqdxpa ahj iag Jouymze egywvqnsmr ggse. Iuv Eyrsgucuelr kvbj nsybmdtkz gwnaik Ahnwx zthhqljei wokdfnd hfvcmznlhu, vv avj Brpltf dke zettjshwageuqv Qgqkwgzybixeb (Helkliwc Nykuiy) gwwfnpmzcycz bgckx.
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The publisher indicated in each case (see company info by clicking on image/title or company info in the right-hand column) is solely responsible for the stories above, the event or job offer shown and for the image and audio material displayed. As a rule, the publisher is also the author of the texts and the attached image, audio and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.