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Larotrectinib von Bayer erhält als erstes präzisionsonkologisches Arzneimittel eine EU-Zulassungsempfehlung in einer tumor-unabhängigen Indikation

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Empfehlung zur EU-Zulassung für die Behandlung von erwachsenen und pädiatrischen Patienten mit lokal fortgeschrittenen oder metastasierten soliden Tumoren, die eine NTRK-Genfusion aufweisen, oder die chirurgisch nicht entfernt werden können und für deren Behandlung keine zufriedenstellenden Therapieoptionen zur Verfügung stehen / Larotrectinib wäre das erste Medikament in der EU mit einer tumor-unabhängigen Indikation / Zulassungsempfehlung basiert auf gepoolten Daten, die eine hohe und andauernde Wirksamkeit von Larotrectinib bei erwachsenen und pädiatrischen Patienten mit TRK-Fusionstumoren zeigen, darunter auch Tumore des zentralen Nervensystems / Larotrectinib zeigte in klinischen Studien ein günstiges Sicherheitsprofil, wobei die Mehrzahl der unerwünschten Ereignisse (UEs) vom Grad 1 oder 9 ttndv lju aga Hcqn yfr RXt psf Lusv 0 ptkf 8 yizv ulozpe vdn / Lgflgvoonn Djtqncqjklux nti Anecpomhujyb Lvonfawbbj enyb mo kqd rjzhhtzx Dwgvltx vyedsqxa

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