← All approvals · Cancer · 2025
Emrelis (telisotuzumab vedotin-tllv)
The FDA approved Emrelis (telisotuzumab vedotin-tllv) on May 14, 2025 to treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy.
- Brand name
- Emrelis
- Generic name
- telisotuzumab vedotin-tllv
- FDA approval date
- May 14, 2025
- Approved use (FDA wording)
- To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy
- Company
- Abbvie Inc.
- Application
- BLA761384
- Dosage form / route
- VIAL · SINGLE-DOSE
- Boxed warning on label
- Not listed
- Category on this site
- Cancer
Indications and usage, from the FDA label
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 [see Dosage and Administration ( 2.1 )] , 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) [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody and microtubul…