FDA Approves FoundationOne CDx for Tepotinib in MET+ NSCLC

The FDA has approved the FoundationOne^® CDx for identifying patients with non–small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations who may benefit from treatment with tepotinib (Tepmetko), according to a press release from the developer, Foundation Medicine, Inc.¹

This approval for FoundationOne CDx represents the first to leverage the companion diagnostic’s real-world data–based service, which supports drug and diagnostic label expansion by supplementing clinical trials with curated real-world evidence and integrated regulatory support.

FoundationOne CDx, a next-generation sequencing-based in vitro diagnostic device, is designed to detect substitutions, insertion and deletion alterations, and copy number alterations across 324 genes and select gene rearrangements. The device is intended exclusively for prescription use to identify patients who may benefit from specific targeted agents in accordance with approved therapeutic product labeling. The press release noted that the test may not guarantee that a patient is matched with a specific treatment, and that a negative result does not exclude the possibility of an alteration.

“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,” Todd Druley, MD, PhD, chief medical officer at Foundation Medicine, stated in the press release.¹ “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.”

The FDA originally approved tepotinib as a treatment for patients with NSCLC harboring MET exon 14 skipping alterations in February 2024.² Supporting data for the approval came from the phase 2 VISION trial (NCT02864992), which evaluated the agent among 313 patients with MET-altered NSCLC.

At the time of the approval, data demonstrated an overall response rate (ORR) of 57% (95% CI, 49%-65%) among 164 patients who received no prior therapy, with 40% of responders experiencing a response duration of at least 12 months. Additionally, the ORR was 45% (95% CI, 37%-53%) among 149 patients with previously treated disease, which included 36% of responders having a sustained response for at least 12 months.

The most common toxicities included edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash.

As part of the phase 2 VISION trial, patients received tepotinib at 450 mg once daily until disease progression or unacceptable toxicity. The primary end point across cohorts A, B, and C in parts 1 and 2 of the trial was ORR per independent review committee assessment.³ Secondary end points included duration of response, disease control rate, progression-free survival, overall survival, and treatment-emergent adverse effects.

Patients 18 years and older with measurable disease per independent review committee evaluation based on RECIST v1.1 criteria, an ECOG performance status of 0 or 1, and histologically or cytologically confirmed advanced NSCLC were eligible for enrollment on the trial. Having MET alterations, namely MET exon 14 skipping alterations in plasma and/or tissue, was another requirement for study entry.

“Innovation in targeted therapies for lung cancer has helped pave the way for progress in precision medicine, but there is still much work needed to connect the right patients to the right therapies, and to find new options for patients. 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,” Danielle Hicks, co-interim chief executive officer and chief patient officer at GO2 for Lung Cancer, concluded in the press release.¹

References

1. 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. News release. Foundation Medicine, Inc. May 21, 2026. Accessed May 26, 2026. https://tinyurl.com/2n6zzadn
2. FDA approves tepotinib for metastatic non-small cell lung cancer. News release. FDA. February 15, 2024. Accessed May 26, 2026. https://bit.ly/3SJD4Wl
3. Tepotinib phase II in NSCLC harboring MET alterations (VISION). ClinicalTrials.gov. Updated April 14, 2026. Accessed May 26, 2026. https://tinyurl.com/47k688n4