U.S. FDA Approves EMRELIS (Telisotuzumab vedotin-tllv) for adults with previously treated advanced Non-Small Cell Lung Cancer (NSCLC) with high c-Met protein overexpression

CAR-T Digest - August 2020

Weekly Digest - May 2025

14 May 2025: U.S. FDA Approves EMRELIS (Telisotuzumab vedotin) for adults with previously treated advanced Non-Small Cell Lung Cancer (NSCLC) with high c-Met protein overexpression

The FDA granted accelerated approval to AbbVie’s EMRELIS (Telisotuzumab vedotin) for adults with previously treated, locally advanced or metastatic non-squamous NSCLC with high c-Met protein overexpression (≥50% strong staining)
Approval is contingent upon achieving a 35% overall response rate and a median duration of response of 7.2 months from the Phase 2 LUMINOSITY Study, continued approval will depend on the results of a confirmatory Phase 3 trial
EMRELIS is the first and only approved antibody-drug conjugate (ADC) for this specific patient group, targeting the c-Met biomarker to deliver a cytotoxic payload directly to cancer cells
The approval marks AbbVie’s first FDA-approved solid tumor treatment in lung cancer and is seen as a significant step in expanding targeted, biomarker-driven cancer therapies