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Bayer Vital GmbH Gebäude K56 51366 Leverkusen, Germany http://www.bayerhealthcare.com
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Bayer Vital GmbH

FDA will Regorafenib bei gastrointestinalen Stroma-Tumoren im vereinfachten Verfahren prüfen

Nicht für US-Medien bestimmt - "Fast Track"-Status für Krebsmedikament

(PresseBox) (Berlin, )
Die US-amerikanische Gesundheitsbehörde Food and Drug Administration wird Regorafenib von Bayer zur Therapie metastasierter und/oder nicht operabler gastrointestinaler Stroma-Tumore (GIST) bei Patienten, deren Erkrankung trotz Behandlung mit mindestens Imatinib und Sunitinib weiter fortgeschritten ist, in einem vereinfachten Verfahren ("Fast Track") prüfen. Dies hat die Behörde jetzt entschieden. Der sogenannte "Fast Track"-Status soll die Entwicklung von Arzneimitteln zur Behandlung schwerer Erkrankungen mit hohem ungedecktem medizinischem Bedarf erleichtern und die Begutachtung durch die FDA beschleunigen. Regorafenib ist ein neuartiger oral wirksamer Multi-Kinase-Inhibitor, der sich in der letzten Phase der klinischen Entwicklung für GIST befindet.

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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.