The US Food and Drug Administration (FDA) has approved FoundationOne CDx as a companion diagnostic to capmatinib, a MET inhibitor for the treatment of metastatic non-small cell lung cancer (NSCLC) harboring MET with an exon 14 (METex14) skipping mutation.1

According to the press release, the approval of capmatinib and its companion diagnostic “marks an important advancement for patients with METex14-mutated metastatic NSCLC, as there have previously been no treatment options available specifically for this diagnosis.”

FoundationOne CDx uses next-generation sequencing to perform comprehensive genomic profiling of solid tumors. The test can detect substitution, insertions and deletions (indels), copy number alterations, some gene rearrangements, microsatellite instability, and tumor mutational burden in formalin-fixed paraffin-embedded tumor tissue. It now has FDA approval for 21 different agents.

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Capmatinib received accelerated approval by the FDA for the treatment of patients with metastatic NSCLC with METex14 in May 2020 based on overall response and duration or response data from the phase 2 GEOMETRY mono-1 trial (NCT02414139).2 The capmatinib indication requires detection of METex14 by an FDA-approved test.3

Reference

  1. Foundation Medicine. Foundation Medicine receives FDA approval for FoundationOne®CDx as the companion diagnostic for Tabrecta™ (capmatinib), the only FDA-approved MET inhibitor for patients with metastatic non-small cell lung cancer with METex14. Press release. May 6, 2020. Accessed May 12, 2020.
  2. US Food and Drug Administration. FDA grants accelerated approval to capmatinib for metastatic non-small cell lung cancer. Press release. May 6, 2020. Accessed May 12, 2020.
  3. Trabecta (capmatinib). [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation. 2020.