publication date: Oct. 30, 2020

Drugs & Targets

FoundationOne CDx test receives FDA approval as companion diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

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).

The FoundationOne CDx test is sponsored by Foundation Medicine. Vitrakvi is sponsored by Bayer Healthcare Pharmaceuticals inc.

Larotrectinib was granted accelerated approval Nov. 26, 2018, for adult and pediatric patients with solid tumors that have a NTRK gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.

Approval of larotrectinib was based on data from three multicenter, open-label, single-arm clinical trials: LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687), and NAVIGATE (NCT02576431).

Identification of positive NTRK gene fusion status was prospectively determined in local laboratories using NGS, fluorescence in situ hybridization, and reverse transcriptase- polymerase chain reaction methods.

NTRK gene fusions were inferred in three pediatric patients with infantile fibrosarcoma who had a documented ETV6 translocation by FISH. The major efficacy outcome measures were overall response rate and response duration, as determined by a blinded independent review committee according to RECIST 1.1.

The FoundationOne CDx assay approval as a companion diagnostic for larotrectinib was based on the retrospective testing with F1CDx of available tumor tissue samples from patients enrolled in the three clinical trials that supported the accelerated approval of larotrectinib. Efficacy for larotrectinib … Continue reading FoundationOne CDx test receives FDA approval as companion diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

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