23.10.20: Not intended for U.S. and UK Media

FDA approves FoundationOne®CDx as companion diagnostic for Vitrakvi™ (larotrectinib) to aid in identifying NTRK fusion-positive patientsThe companion diagnostic (CDx) approval is part of the global collaboration between Bayer and Foundation Medicine, Inc. for the development and commercialization of next-generation sequencing (NGS)-based companion diagnostics in oncology / Detection of genomic alterations that drive the growth and spread of the tumor can guide treatment decisions for cancer therapies, such as available biomarker driven therapies / FoundationOne®CDx analyzes substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes as well as select rearrangements and genomic signatures across all solid tumors, including the three NTRK gene fusions (NTRK1, NTRK2 and NTRK3), to inform treatment decisions(1) / Vitrakvi™ (larotrectinib) is the first and only TRK-specific inhibitor approved in the U.S. for adult and pediatric patients with TRK fusion cancer across all solid tumors and is under review in other markets around the worldmehr ...
Source: Bayer IR Newsfeed: Events - Category: Pharmaceuticals Source Type: news