FDA Approves First Targeted Therapy for Advanced Lung Cancer with High c-Met Protein

New Option for Hard-to-Treat NSCLC

Charles H. Weaver, MD
1–2 minutes
Home » Lung Cancer » FDA Approves First Targeted Therapy for Advanced Lung Cancer with High c-Met Protein

The FDA has granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv), the first targeted therapy for adults with advanced non-squamous non-small cell lung cancer (NSCLC) whose tumors have high levels of a protein called c-Met. This offers hope for patients who have exhausted prior treatments.

Who Can Benefit?

  • Adults with locally advanced or metastatic non-squamous NSCLC that tests positive for high c-Met protein overexpression (≥50% of tumor cells show strong staining).
  • Patients who have already received at least one systemic therapy (e.g., chemotherapy or immunotherapy).

A companion diagnostic test, VENTANA MET (SP44) RxDx Assay, is also approved to identify eligible patients.

How Emrelis Works

Emrelis is an antibody-drug conjugate (ADC) designed to:

  1. Target c-Met proteins on cancer cells.
  2. Deliver a chemotherapy drug (MMAE) directly into tumors, sparing healthy cells.
    It is given as an IV infusion every two weeks until the cancer progresses or side effects become unmanageable.

What the Clinical Trial Showed

In the LUMINOSITY trial (84 patients with high c-Met NSCLC):

  • 35% of patients saw their tumors shrink (response rate).
  • Responses lasted a median of 7.2 months.
  • EGFR wild-type patients were included, meaning the drug is for those without specific genetic mutations.

Side Effects

Common side effects (≥20% of patients):

  • Peripheral neuropathy (nerve damage in hands/feet).
  • Fatigue.
  • Decreased appetite.
  • Swelling in limbs (peripheral edema).

Serious but rare risks include lung inflammation and vision changes. Dose adjustments or discontinuation may be needed for severe reactions.

What Patients Should Know

  • Accelerated approval means continued availability depends on confirmatory trials.
  • Ask your oncologist about c-Met testing to determine eligibility.
  • Emrelis is not a cure but may help control advanced disease.

More Reading

Newly Diagnosed With Lung Cancer? What Every Patient Should Know

The Importance of Molecular Testing

Precision Medicines & Immunotherapy

Must Read Tips for Beating Lung Cancer

Join the conversation on Cancer Connect.

References

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression?utm_medium=email&utm_source=govdelivery

Camidge DR, Bar J, Horinouchi H, et al. Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein-Overexpressing Advanced Nonsquamous EGFR-Wildtype Non-Small Cell Lung Cancer in the Phase II LUMINOSITY Trial. J Clin Oncol. 2024 Sep 1;42(25):3000-3011.

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