FDA moves to expand tissue testing for targeted lung cancer therapy

The FDA approved Foundation Medicine’s FoundationOne CDx as a companion diagnostic for EMD Serono’s Tepmetko (tepotinib) to identify metastatic non-small cell lung cancer patients with MET exon 14 skipping alterations eligible for treatment. The label expands Foundation’s prior diagnostic coverage by adding a tissue-based option and aligning it with the company’s earlier liquid biopsy assay approval. The approval supports both sample types—tissue and liquid—under the Tepmetko companion diagnostic footprint, addressing a common real-world constraint where adequate tissue may be limited. MET exon 14 skipping alterations occur in roughly 3–4% of NSCLC tumors, leaving a targeted testing pathway central to patient identification.