FDA Approves Companion Diagnostic to Identify NTRK Fusions in Solid Tumors
On Friday October 23rd, 2020, the FDA approved the FoundationOne CDx assay (Foundation Medicine) as a companion diagnostic tool using next-generation sequencing(NGS) to identify neurotrophic receptor tyrosine kinase fusions (NTRK1, NTRK2, NTRK3) in DNA isolated from solid tumor tissue specimens eligible for treatment with larotrectinib.
The approval of the FoundationOne CDx assay as a companion diagnostic for larotrectinib is based on retrospective testing with the assay of available tumor tissues samples from patients enrolled in the three clinical trials (LOXO-TRK-14001; SCOUT; NAVIGATE) that led to FDA approval of larotrectinib in 2018.
Larotrectinib was approved for adult and pediatric patients with solid tumors that have a NTRK gene fusion without known acquired resistance mutation, with metastatic or unresectable disease, experiencing disease progression with no alternative treatments.
The primary endpoints of those trials were overall response rate and response duration, determined by blinded independent review committee according to RECIST 1.1.
Efficacy of larotrectinib was maintained in patients with confirmed NTRK fusion positive results by the FoundationOne CDx assay. In addition to NTRK gene fusions, the FoundationOne CDx assay is a NGS-based in vitro diagnostic device that’s capable of detecting several other mutations. —Kaitlyn Manasterski
Source: US Food and Drug Administration. FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi. Updated October 26, 2020. https://www.fda.gov/drugs/fda-approves-companion-diagnostic-identify-ntrk-fusions-solid-tumors-vitrakvi?utm_medium=email&utm_source=govdelivery Accessed: October 26, 2020.
