What Was Approved?
On May 14, 2025, the U.S. Food and Drug Administration granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv) for adults with locally advanced or metastatic non-squamous non-small cell lung cancer, or NSCLC, with high c-Met protein overexpression who have received prior systemic therapy.
High c-Met expression is defined in the FDA label as at least 50% of tumor cells showing strong (3+) staining, as determined by an FDA-approved test.
How Does Emrelis Work?
Emrelis is a c-Met-directed antibody-drug conjugate.
It is designed to bind to c-Met on tumor cells and deliver a microtubule-disrupting drug into those cells.
How Is Emrelis Given?
The recommended dose is:
1.9 mg/kg by intravenous infusion once every 2 weeks.
Treatment generally continues until disease progression or unacceptable toxicity.
Why Was It Granted Accelerated Approval?
FDA granted accelerated approval based on overall response rate and duration of response in the LUMINOSITY study.
Continued approval may depend on confirmatory evidence of clinical benefit.
What Are the Main Safety Concerns?
Important FDA warnings include:
- Peripheral neuropathy
- Interstitial lung disease or pneumonitis
- Ocular surface disorders
- Infusion-related reactions
- Embryo-fetal toxicity
Common adverse reactions included peripheral neuropathy, fatigue, decreased appetite, and peripheral edema.
Bottom Line
Emrelis (telisotuzumab vedotin-tllv) is an FDA-approved targeted antibody-drug conjugate for certain previously treated adults with high c-Met-overexpressing non-squamous NSCLC.
Because eligibility depends on specific tumor testing and the approval is accelerated, treatment requires oncology supervision and appropriate biomarker testing.
Sources
- U.S. Food and Drug Administration (FDA) — FDA Grants Accelerated Approval to Telisotuzumab Vedotin-tllv for NSCLC With High c-Met Protein Overexpression, May 14, 2025.
- U.S. Food and Drug Administration (FDA) — Emrelis Prescribing Information, May 2025.
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Emrelis.