On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
FDA also approved the VENTANA MET (SP44) RxDx Assay (Roche Diagnostics) as a companion diagnostic test to aid in detecting c-Met protein overexpression in patients with non-squamous NSCLC who may be eligible for treatment with Emrelis.
Full prescribing information for Emrelis will be posted on Drugs@FDA.
Efficacy was evaluated in the LUMINOSITY study (NCT03539536), a multicenter, open label, multi-cohort trial. The trial included 84 patients with epidermal growth factor receptor (EGFR) wild-type, non-squamous NSCLC with high c-Met protein overexpression who had received prior systemic therapy.
The major efficacy outcome measures were confirmed overall response rate (ORR) and duration of response (DOR), determined by blinded independent central review (BICR) according to RECIST 1.1. ORR was 35% (95% CI: 24, 46) and median DOR was 7.2 months (95% CI: 4.2, 12).
In a pooled safety population, the most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium.
The recommended telisotuzumab vedotin-tllv dose is 1.9 mg/kg (up to a maximum of 190 mg for patients ≥100 kg), as an intravenous infusion every 2 weeks, until disease progression or unacceptable toxicity.
This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
This application was granted priority review and breakthrough designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.
Follow the Oncology Center of Excellence on X: @FDAOncology.
