FDA clears FoundationOne companion test for lung cancer drug

2020 05 06 20 51 7505 Lung Patient Consultation 400

Foundation Medicine's FoundationOne companion diagnostic has been cleared by the U.S. Food and Drug Administration (FDA) for a new indication in guiding treatment with the targeted drug capmatinib (Tabrecta, Novartis) for some patients with metastatic non-small cell lung cancer (NSCLC).

Tabrecta is an inhibitor of mesenchymal-epithelial transition (MET). The drug was just approved by the FDA for use in adults with metastatic NSCLC and a mutation that leads to MET exon 14 (METex14) skipping, which is present in some 4,000 to 5,000 people annually in the U.S. and has been difficult to treat in the past. The FoundationOne test is a broad genomic profiling tool for solid tumors and is now cleared for use in guiding treatment with a total of 21 drug therapies.

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