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FDA Approves Foundation Medicine CDx, Bayer's Vitrakvi for NTRK Patients

NEW YORK – Foundation Medicine announced on Friday its FoundationOne CDx test received approval from the US Food and Drug Administration for use with larotrectinib (Bayer's Vitrakvi) to help identify cancer patients with neurotrophic receptor tyrosine kinase fusions. 

Foundation's comprehensive genomic profiling test analyzes substitutions, insertion and deletion alterations, and copy number alterations in 324 genes, along with select rearrangements and genomic signatures across all solid tumors. Those signatures include the three NTRK gene fusions, which are more commonly found in rare cancer types such as secretory carcinoma of the breast, Foundation said in a statement. The test is approved as a companion diagnostic for more than 20 therapies, the company added. The Roche subsidiary said the approval is part of a collaboration between Bayer and Foundation Medicine to develop and commercialize next-generation sequencing-based companion diagnostics in oncology. 

Larotrectinib is approved in the US for refractory patients with TRK fusion-positive solid tumors who don't have a known acquired resistance mutation. It is approved for patients who are metastatic, or in cases where surgical resection is "likely to result in severe morbidity," Bayer said.

Chugai Pharmaceuticals, a Foundation Medicine partner in Japan, filed an application with the Japanese Ministry of Health, Labour, and Welfare for expanded use of FoundationOne CDx with larotrectinib, Bayer said.