FDA Grants Accelerated Approval to Telisotuzumab Vedotin-tllv for NSCLC

By: JNCCN 360 Staff
Posted: Thursday, May 15, 2025

The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to a c-Met-directed antibody and microtubule inhibitor conjugate, telisotuzumab vedotin-tllv, for non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression who have received a prior systemic therapy. High c-Met protein overexpression must be determined by an FDA-approved test and be ≥50% of tumor cells with strong (3+) staining.  

The accelerated approval was granted based on data from the LUMINOSITY study (NCT03539536). LUMINOSITY is a multicenter, open label, multi-cohort trial currently looking at efficacy of telisotuzumab vedotin-tllv in patients with EGFR wild-type, non-squamous NSCLC with high c-Met protein overexpression who had received prior systemic therapy. For the 84 patients in the study, the overall response rate was 35% (95% CI: 24, 46), and the median duration of response was 7.2 months (95% CI: 4.2, 12). The most common adverse reactions were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. 

The recommended dosage is 1.9 mg/kg as an intravenous infusion every 2 weeks, with a maximum of 190 mg for patients ≥100 kg. The FDA also approved the VENTANA MET (SP44) RxDx Assay as a companion diagnostic test to aid in detecting c-Met protein overexpression which may assist in determining if patients are eligible for telisotuzumab vedotin-tllv treatment. 

U.S. Food and Drug Administration

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