The Lynx Group

FoundationOne CDx Approved as Companion Diagnostic for Vitrakvi to Identify NTRK Fusions in Solid Tumors

December 2020, Vol 11, No 6

On October 23, 2020, the FDA approved the FoundationOne CDx diagnostic test as a companion diagnostic to identify fusions in the NTRK1, NTRK2, and NTRK3 genes in patients who are eligible for treatment with larotrectinib (Vitrakvi).

Larotrectinib is approved for adults and pediatric patients with solid tumors that harbor a NTRK gene fusion without a known acquired resistance mutation and who have no viable alternative treatment options or whose cancer has progressed after receiving treatment.

The FDA approved the FoundationOne CDx assay as a companion diagnostic for larotrectinib based on the results of retrospective testing of available tumor tissue samples from patients enrolled in the 3 multicenter, open-label, single-arm clinical trials that supported the accelerated approval of larotrectinib. The efficacy of larotrectinib was maintained in the patients with confirmed NTRK fusions as detected by FoundationOne CDx.

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