The tissue-based test identifies patients with MET exon 14 skipping alterations eligible for treatment with tepotinib.
The US Food and Drug Administration (FDA) has approved FoundationOne CDx as a companion diagnostic for Tepmetko (tepotinib) to identify adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations (METex14).
Tepmetko, developed by EMD Serono, received accelerated FDA approval in February 2021 and traditional FDA approval in February 2024 for the treatment of adult patients with metastatic non-small cell lung cancer harboring METex14. METex14 alterations are found in 3% to 4% of non-small cell lung cancer cases and are often associated with advanced disease and a poor prognosis, according to a press release from Foundation Medicine.
Integration of Real-World Data
This approval represents the first time Foundation Medicine has leveraged its real-world data-powered companion diagnostic offering for a regulatory milestone. The service uses evidence from the Flatiron Health-Foundation Medicine Clinico-genomic Database, which contains data from more than 150,000 patients, to supplement clinical trials and reduce the need for incremental patient enrollment.
“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,” says Todd Druley, MD, PhD, chief medical officer at Foundation Medicine, in a release. “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.”
Expanding Testing Options
Foundation Medicine now offers both tissue and blood-based genomic profiling tests approved by the FDA for this therapy. In November 2024, the company’s blood-based test, FoundationOne Liquid CDx, became the first FDA-approved companion diagnostic for Tepmetko. The FoundationOne CDx tissue-based test analyzes more than 300 cancer-related genes in a patient’s tumor.
“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,” says Danielle Hicks, co-interim CEO and chief patient officer at GO2 for Lung Cancer, in a release. “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 currently has more than 20 FDA-approved companion diagnostic indications for non-small cell lung cancer and more than 100 indications in total, according to the company.
