BOSTON — Foundation Medicine said the U.S. Food and Drug Administration has approved FoundationOne CDx as a companion diagnostic for TEPMETKO, a targeted therapy used to treat certain adults with metastatic non-small cell lung cancer.
The approval allows FoundationOne CDx, a tissue-based comprehensive genomic profiling test, to be used to identify patients whose tumors have MET exon 14 skipping alterations and who may be eligible for treatment with TEPMETKO, or tepotinib. The drug was developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada.
TEPMETKO received accelerated FDA approval in February 2021 and traditional approval in February 2024 for adult patients with metastatic non-small cell lung cancer whose tumors carry MET exon 14 skipping alterations.
Foundation Medicine said the approval expands testing options for patients and physicians. In November 2024, the company’s blood-based test, FoundationOne Liquid CDx, became the first FDA-approved companion diagnostic to identify patients who may be eligible for TEPMETKO.
The company said the latest approval is also its first companion diagnostic approval supported by its real-world data-powered offering. The service uses real-world evidence and regulatory support to help expand drug and diagnostic labels, supplementing clinical trial data when additional patient enrollment may be difficult.
Foundation Medicine said the approval drew on data from more than 150,000 patients in the Flatiron Health-Foundation Medicine Clinico-Genomic Database.
“This approval reinforces the importance of having diverse, high-quality testing options to support healthcare providers in making informed treatment decisions for their patients, regardless of available sample type,” said Todd Druley, M.D., Ph.D., Chief Medical Officer at Foundation Medicine. “This milestone also highlights our commitment to finding novel avenues to enable expanded patient access. In the many cases where samples are depleted and the time needed for a new trial is unfeasible, rigorous, regulatory-aligned real-world evidence can complement pre-existing clinical trial data to help expand the available options for patients.”
MET exon 14 skipping alterations are found in about 3% to 4% of non-small cell lung cancer cases and are commonly associated with advanced disease and poor prognosis, according to the company.
“Innovation in targeted therapies for lung cancer has helped pave the way for progress in precision medicine, but there is still so much work needed to connect the right patients to the right therapies, and to find new options for patients,” said Danielle Hicks, Co-Interim Chief Executive Officer and Chief Patient Officer at GO2 for Lung Cancer. “We’re excited to see the value that regulatory-grade, real-world data can add to increase agility, while maintaining the highest standards for patient care.”
Foundation Medicine said it now has more than 20 FDA-approved companion diagnostic indications for non-small cell lung cancer and more than 100 approved companion diagnostic indications overall.
FoundationOne CDx analyzes more than 300 cancer-related genes using a tissue sample. Foundation Medicine said it is the only company with both tissue- and blood-based comprehensive genomic profiling tests approved by the FDA.
