【FDA Approval Alert】AbbVie’s telisotuzumab vedotin-tllv (Emrelis) Accelerated Approval for High c-Met Non-Small Cell Lung Cancer (May 14, 2025)
On May 14, 2025, the U.S. FDA granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis) for adults with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (≥50% tumor cells with strong 3+ staining). The approval is based on the LUMINOSITY trial (NCT03539536). The VENTANA MET (SP44) RxDx Assay (Roche Diagnostics) was concurrently approved as a companion diagnostic.
Disease Overview: High c-Met Non-Small Cell Lung Cancer
High c-Met NSCLC is a molecular subtype characterized by MET protein overexpression, driving tumor growth and metastasis. Targeted therapy options are emerging for this subgroup.
Treatment Summary
- Drug Name: telisotuzumab vedotin-tllv (Emrelis)
- Company: AbbVie Inc.
- Approval Date: May 14, 2025
- Indication: Previously treated high c-Met non-squamous NSCLC
- Mechanism of Action: c-Met-directed antibody–drug conjugate (ADC)
- Pivotal Trial: LUMINOSITY (NCT03539536)
- Key Efficacy: ORR 35% (95% CI: 24–46), Median DOR 7.2 months
Patient-Friendly Summary
Emrelis is an antibody-drug conjugate that targets c-Met on tumor cells, providing a new treatment option for patients with previously treated high c-Met NSCLC.
M&A Information
- Subsidiary: Not applicable (AbbVie in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (NYSE: ABBV)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
