US EditionFDA OKs New Drug for Lung Cancer With c-Met Overexpression
- The FDA granted accelerated approval in May 2025 to AbbVie's telisotuzumab vedotin-tllv for adults with advanced non-squamous NSCLC showing high c-Met protein overexpression after prior systemic therapy.
- This approval followed positive results from the ongoing phase 2 LUMINOSITY trial, which enrolled patients with high c-Met expression and demonstrated an overall response rate around 35% with some variation in reported median duration of response.
- The trial included 84 eligible patients identified using the FDA-approved Roche VENTANA MET immunohistochemistry test, which served as a companion diagnostic to select candidates for this targeted antibody-drug conjugate treatment.
- Emrelis demonstrated an overall response rate of 35% with a median response duration of approximately 7.2 months. The treatment was commonly associated with side effects such as nerve-related symptoms, tiredness, reduced appetite, and swelling in the extremities.
- This first-in-class therapy addresses a critical unmet need in c-Met overexpressing NSCLC, and ongoing confirmatory trials will determine its long-term clinical benefit and potential to improve patient outcomes.
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MedPage Today
Anti-Aging, Acupuncture and Health NewsFDA OKs New Drug for Lung Cancer With c-Met Overexpression
(MedPage Today) -- The FDA granted accelerated approval to telisotuzumab vedotin (Emrelis) for the treatment of adults with previously treated, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein...
FDA Approves Emrelis (telisotuzumab vedotin-tllv) for High c-MET Expressing NSCLC - GO2 for Lung Cancer
×Did you know? There are different kinds of changes, called mutations, that can happen in the MET gene. These changes can help cancer grow and spread. One type is called c-MET overexpression. This means the cancer cells make too much of a protein called c-MET. On May 14, 2025, the U.S. Food and Drug Administration (FDA) announced accelerated approval of Emrelis (telisotuzumab vedotin-tllv) for people with locally advanced or metastatic, non-squa…
Prospective multicenter validation of a next-generation sequencing panel using cytology specimens for lung cancer: cPANEL
Background There are no prospective studies to estimate whether cytology specimens can replace tissue samples using lung cancer gene panel analysis. We evaluated the success rate of gene panel testing and nucleic acid yield and quality when using cytology speci...
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