Fda approves FoundationOne CDx as an accompanying diagnostic agent for Vitrakvi (larotrectinib) to help identify NTRK fusion-positive patients.

In the United States, Vitrakvi ® can be used to treat patients with metastasis solid tumors with NTRK gene fusion but no known gain resistance mutations.
. Bayer recently announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne®CDx as the first accompanying diagnostic method to help identify patients who may be suitable for neurotrophic ligenics Tyrosine kinase (NTRK) fusion that may be suitable for treatment with Vitrakvi®
One CDx is an FDA-approved Comprehensive Genomic Analysis (CGP) test for all solid tumors.
Vitrakvi has a good clinical performance and is the only treatment specifically developed for patients with TRK fusion cancer," said Robert Lacaz, executive director of Bayer Pharmaceuticals.
FDA's approval of FoundationOne CDx allows us to more accurately identify patients who may benefit from this treatment.
We look forward to working globally with Foundation Medicine to expand cancer detection and determine the right treatment."
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