Emrelis FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 30, 2024.
FDA Approved: Yes (First approved May 14, 2025)
Brand name: Emrelis
Generic name: telisotuzumab vedotin-tllv
Dosage form: Lyophilized Powder for Injection
Previous Name: Teliso-V
Company: AbbVie Inc.
Treatment for: Non Small Cell Lung Cancer
Emrelis (telisotuzumab vedotin) is a first-in-class, c-Met protein directed antibody-drug conjugate for the treatment of non-squamous non-small cell lung cancer with high c-Met protein overexpression.
- Emrelis is indicated for the treatment of adult patients 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.
- This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). - The c-Met protein is a receptor tyrosine kinase that can be overexpressed in many solid tumors, including NSCLC.
Development timeline for Emrelis
Further information
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