May 14, 2025—AbbVie announced that Emrelis (telisotuzumab vedotin-tllv) has been granted accelerated approval by the FDA for the treatment of adult patients with locally advanced or metastatic, nonsquamous non-small cell lung cancer with high c-Met protein overexpression who have received a prior systemic therapy. High c-Met protein overexpression is defined as ≥50 percent of tumor cells with strong (3+) staining as determined by an FDA-approved test.
The approval is supported by data from the phase tw0 Luminosity study, designed to characterize the efficacy and safety of Emrelis in c-Met overexpressing advanced NSCLC populations. Findings from the study showed patients with high c-Met protein overexpression (n=84) who received Emrelis demonstrated a 35 percent (95 percent confidence interval [CI], 24, 46) overall response rate and duration of response with a median of 7.2 months (95 percent CI, 4.2, 12).
The FDA also approved the Roche Ventana MET (SP44) RxDx assay as a companion diagnostic test to aid in detecting c-Met protein overexpression in patients with nonsquamous NSCLC who may be eligible for treatment with Emrelis.