FDA
Emrelis OK’d for NSCLC with high c-Met protein overexpression
Brand name: Emrelis
Generic name: telisotuzumab vedotin-tllv
Manufacturer: AbbVie
Approval date: May 14, 2025
FDA granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv), 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’ve 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.
Efficacy
Efficacy was evaluated in the phase 2 LUMINOSITY study (NCT03539536), a multicenter, open label, multi-cohort trial involving 84 patients with epidermal growth factor receptor (EGFR) wild-type, non-squamous NSCLC with high c-Met protein overexpression who’d received prior systemic therapy.
The major efficacy outcome measures were confirmed overall response rate (ORR) and duration of response (DOR). ORR was 35% (95% CI, 24-46) and median DOR was 7.2 months (95% CI, 4.2-12).
Safety
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 lab abnormalities (≥2%) were decreased lymphocytes, increased glucose, increased ALT, increased GGT, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium.
Recommended dose
The recommended dosage of telisotuzumab vedotin-tllv is 1.9 mg/kg (max. 190 mg for patients ≥100 kg), as an IV infusion q2wks, until disease progression or unacceptable toxicity.
Sources:
FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression. [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression
US FDA approves Emrelis™ (telisotuzumab vedotin-tllv) for adults with previously treated advanced non-small cell lung cancer (NSCLC) with high c-Met protein overexpression. [News release]. 2025. https://news.abbvie.com/2025-05-14-U-S-FDA-Approves-EMRELIS-TM-telisotuzumab-vedotin-tllv-for-Adults-With-Previously-Treated-Advanced-Non-Small-Cell-Lung-Cancer-NSCLC-With-High-c-Met-Protein-Overexpression
Emrelis (telisotuzumab vedotin-tllv) [package insert]. Abbvie. https://www.rxabbvie.com/pdf/emrelis_pi.pdf Revised May 2025. Accessed May 19, 2025.