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Bayer beantragt in China Zulassung des präzisionsonkologischen Medikaments Larotrectinib

Zulassung beantragt für die Behandlung von erwachsenen und pädiatrischen Patienten mit fortgeschrittenen soliden Tumoren mit einer NTRK-Genfusion (neurotrophe Tyrosin-Rezeptor-Kinase)

(PresseBox) (Berlin, )
Bayer hat einen Zulassungsantrag für Larotrectinib beim Center for Drug Evaluation (CDE) der chinesischen Arzneimittelbehörde NMPA (National Medical Products Administration) eingereicht. Der Antrag bezieht sich auf die Behandlung von erwachsenen und pädiatrischen Patienten mit fortgeschrittenen soliden Tumoren mit einer NTRK-Genfusion (neurotrophe Tyrosin-Rezeptor-Kinase). Larotrectinib ist ein oraler Inhibitor der Tropomyosin Rezeptor-Kinase (TRK-Inhibitor), der speziell für Tumore mit einer NTRK-Genfusion entwickelt wurde. Das Produkt ist in mehr als vierzig Ländern unter dem Markennamen Vitrakvi™ zugelassen, darunter in den USA, Ländern der Europäischen Union und Japan. Zulassungsanträge für andere Regionen laufen oder sind geplant.

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