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Drugs & Targets

FDA approves first companion diagnostic for lung cancer drug

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FDA has approved FoundationOne Liquid CDx to be used as a companion diagnostic for Tepmetko (tepotinib) developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada. Tepmetko received accelerated approval from FDA in February 2021 and traditional approval in February 2024 for the treatment of adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations. FoundationOne Liquid CDx is the first FDA-approved companion diagnostic to identify patients who may be eligible for Tepmetko.

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