First-in-class Antibody-drug Conjugate Approved for Non-small Cell Lung Cancer
The FDA has approved telisotuzumab vedotin-tllv for certain patients with non-small cell lung cancer.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis) for the treatment of adult patients with nonsquamous non-small cell lung cancer (NSCLC) that is locally advanced or metastatic, has been previously treated with systemic therapy, and is characterized by high c-Met overexpression, defined as more than half of tumor cells showing strong expression.
Additionally, the FDA approved the VENTANA MET (SP44) RxDx Assay companion diagnostic test for evaluating c-Met protein overexpression.
Telisotuzumab vedotin-tllv is an antibody-drug conjugate that delivers a cell-killing compound to cells expressing the c-Met protein. This is the first FDA approval for telisotuzumab vedotin-tllv, which represents the first c-Met-targeted antibody-drug conjugate for patients with lung cancer that overexpresses c-Met, which is linked to poor prognosis and therapeutic resistance. Unlike other FDA-approved lung cancer treatments that target c-Met, all of which are only approved for tumors that harbor altered versions of c-Met, telisotuzumab vedotin-tllv uses an antibody to target cells that overexpress a normal version of the protein.
The approval is based on results from the multicenter, open label, multicohort phase II LUMINOSITY trial that involved 84 patients with high c-Met-overexpressing nonsquamous NSCLC who had received prior systemic therapy.
Thirty-five percent of patients’ tumors responded to telisotuzumab vedotin-tllv, and half of these patients experienced responses lasting at least 7.2 months.
The recommended dose for telisotuzumab vedotin-tllv is 1.9 mg/kg, not to exceed 190 mg for patients who weigh 100 kg or more, administered intravenously every two weeks until disease progression or unacceptable toxicity.
NSCLC is the most common type of lung cancer, which itself is the third most commonly diagnosed non-skin cancer. According to federal statistics, it was estimated that 226,650 individuals would be diagnosed with lung cancer and 124,730 would die of the disease in the United States in 2025.
The FDA rendered its decision on May 14, 2025. Accelerated approval means that continued approval may be contingent upon a confirmatory trial. Please check this FDA web page for information about any accelerated approvals in oncology that may have been subsequently withdrawn and are no longer FDA-approved. Check this resource for updated information on all therapeutics regulated by the FDA.