The next-generation sequencing-based FoundationOne CDx test has received FDA approval as a companion diagnostic to identify fusions in neurotrophic receptor tyrosine kinase genes, NTRK1, NTRK2, and NTRK3, in DNA isolated from tumor tissue specimens from patients with solid tumors eligible for treatment with Vitrakvi (larotrectinib).
Richard Pazdur, FDA’s top oncologist who last week received a battlefield promotion to the role of director of the FDA Center for Drug Evaluation and Research, is described as a stabilizing figure respected by major patient groups, oncology professional societies, and the industry.
