FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression
Regulatory approval: On May 14, 2025, the FDA granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis) for adults with locally advanced or metastatic, non-squamous NSCLC with high c-Met protein overexpression (≥50% of tumor cells with strong [3+] staining) by an FDA-approved test, after prior systemic therapy. Approval was supported by LUMINOSITY (NCT03539536), with confirmed ORR 35% and median DOR 7.2 months. FDA also approved the VENTANA MET (SP44) RxDx Assay as a companion diagnostic.
FDA accelerated approval (May 14, 2025)
The FDA granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis; AbbVie), a c-Met–directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous NSCLC with high c-Met protein overexpression—defined as ≥50% of tumor cells with strong (3+) staining—as determined by an FDA-approved test, who have received prior systemic therapy.
The FDA also approved the VENTANA MET (SP44) RxDx Assay (Roche Diagnostics) as a companion diagnostic to aid detection of c-Met protein overexpression in patients with non-squamous NSCLC who may be eligible for Emrelis.
Efficacy evidence
Efficacy was evaluated in LUMINOSITY (NCT03539536), a multicenter, open-label, multi-cohort trial. The relevant cohort included 84 patients with EGFR wild-type, non-squamous NSCLC with high c-Met overexpression previously treated with systemic therapy.
Major endpoints were confirmed ORR and DOR by blinded independent central review (RECIST 1.1):
- ORR: 35% (95% CI, 24–46)
- Median DOR: 7.2 months (95% CI, 4.2–12)
Safety and dosing (label highlights)
In a pooled safety population, common adverse reactions (≥20%) were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. Recommended dose: 1.9 mg/kg IV every 2 weeks (max 190 mg for patients ≥100 kg) until progression or unacceptable toxicity.
The review used RTOR; the application received priority review and breakthrough designation.