U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for TEPMETKO® (tepotinib) to Identify Patients with MET Exon 14 Skipping Alterations in Non-Small Cell Lung Cancer

Original from: business wire

Foundation Medicine, Inc., a global, patient-focused precision medicine company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic (CDx) 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 the FDA in February 2021 and traditional approval in February 2024 for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations (METex14).

METex14 is found in 3-4% of NSCLC cases and is commonly associated with advanced disease and a poor prognosis. In November 2024, through Foundation Medicine’s longstanding partnership with Merck KGaA, Darmstadt, Germany, Foundation Medicine’s high-quality blood-based comprehensive genomic profiling test, FoundationOne®Liquid CDx, became the first FDA-approved companion diagnostic to identify patients who may be eligible for TEPMETKO.

FoundationOne CDx as a companion diagnostic for this therapy marks the company’s first approval leveraging its real-world data-powered CDx offering, a service that supports drug and diagnostic label expansion by supplementing clinical trials with expertly curated real-world evidence and integrated regulatory support. Drawing on data from over 150,000 patients in the Flatiron Health-Foundation Medicine Clinico-genomic Database (CGDB), Foundation Medicine is well-positioned to generate relevant and harmonized real-world data (RWD) cohorts reducing the need for incremental patient enrollment while maintaining the rigor required for regulatory use in companion diagnostic projects.

Foundation Medicine is the global leader in companion diagnostic indications. With today’s approval, it has more than 20 FDA-approved companion diagnostic indications for NSCLC, and over 100 approved companion diagnostic indications in total, the most of any comprehensive genomic profiling company.

“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.”

“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 is the only company to offer both tissue and blood-based comprehensive genomic profiling tests that are approved by the FDA. Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes in a patient’s tumor.

Source: U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for TEPMETKO® (tepotinib) to Identify Patients with MET Exon 14 Skipping Alterations in Non-Small Cell Lung Cancer