FDA approves FoundationOne CDx test as companion diagnostic for Vitrakvi
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The FDA approved the FoundationOne CDx test to help identify certain neurotrophic receptor tyrosine kinase gene fusions in patients with solid tumors eligible for treatment with larotrectinib, according to a press release from the agency.
The approval applies to use of the next-generation sequencing-based assay to detect NTRK1, NTRK2 and NTRK3 gene fusions in tumor tissue DNA of these patients.
The FDA granted accelerated approval to larotrectinib (Vitrakvi, Bayer),
a selective tropomyosin receptor kinase inhibitor, in 2018 for adults and children with solid tumors that harbor NTRK gene fusions without a known acquired resistance mutation. The larotrectinib approval includes patients with metastatic disease or disease where surgical resection is likely to result in severe morbidity, those with no alternative treatment options and those whose cancer progressed after treatment.
The agency based its approval of the FoundationOne CDx test (Foundation Medicine) as a companion diagnostic for larotrectinib on retrospective testing of available tumor tissue samples from patients enrolled in three clinical trials that led to the accelerated approval of larotrectinib.
Results showed maintained efficacy of larotrectinib among patients with NTRK fusion-positive tumors identified by the FoundationOne CDx test.
The test is capable of detecting several mutations in addition to NTRK gene fusions, according to the press release.
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