Bayer secured the US Food and Drug Administration (FDA) approval for FoundationOneCDx as a companion diagnostic to identify neurotrophic receptor tyrosine kinase (NTRK) gene fusion-positive patients, eligible for treatment with Vitrakvi (larotrectinib).
FoundationOne CDx is a genomic profiling (CGP) test, previously approved by the US FDA for all solid tumours that incorporate multiple companion diagnostic indications.
TRK fusion cancer is a result of NTRK gene fusion with another unrelated gene, which produces an altered TRK protein, dubbed TRK fusion protein. The altered protein becomes overexpressed, and triggers a signaling cascade.
The cancer occurs in various adult and paediatric solid tumours, including lung, thyroid, GI cancers, sarcoma, CNS cancers, salivary gland cancers and paediatric cancers.
Bayer oncology strategic business unit head Robert LaCaze said: “Vitrakvi has a demonstrated clinical profile and is the only approved treatment specifically developed for patients with TRK fusion cancer.
“The US FDA approval of FoundationOne CDx for Vitrakvi allows patients who may benefit from this treatment to be identified in a more precise way. We look forward to continuing our global collaboration with Foundation Medicine by expanding access to testing and determining the right treatment options for patients with cancer.”
FDA approved FoundationOneCDx under its accelerated approval initiative
Vitrakvi is an approved therapy for NTRK gene fusion-positive solid tumours, without known acquired resistance mutation, where surgical resection would induce severe morbidity, and with no alternative treatments or progressed after treatment.
The FDA approval for FoundationOneCDx has been granted under accelerated approval based on overall response rate and duration of response. Continued approval is subject to verification and description of clinical benefit in confirmatory trials, said the company.
Vitrakvi has been approved in 42 countries, including the US, Canada, Brazil and the European Union (EU), and the company plans to file additional regulatory applications in other regions.
