EMRELIS
EMRELIS (telisotuzumab vedotin-tllv) is a c-Met-directed antibody-drug conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). It is specifically for patients whose tumors exhibit high c-Met protein overexpression, defined as at least 50% of tumor cells with strong staining as determined by an FDA-approved test. This therapy is intended for use in patients who have previously received systemic therapy. The drug received accelerated approval based on response rates, and its continued approval may be contingent upon verification of clinical benefit in confirmatory trials.
How EMRELIS Works
Telisotuzumab vedotin-tllv consists of a humanized IgG1κ antibody directed against the c-Met receptor conjugated to a microtubule-disrupting agent called MMAE. Upon binding to c-Met-expressing tumor cells, the conjugate is internalized and the MMAE payload is released through intracellular cleavage. Once released, MMAE disrupts the microtubule network within actively dividing cells. This process leads to cell cycle arrest and induces apoptotic cell death.
Details
- Status
- Prescription
- First Approved
- 2025-05-14
- Routes
- SINGLE-DOSE
- Dosage Forms
- VIAL
EMRELIS Approval History
What EMRELIS Treats
1 indicationsEMRELIS is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
EMRELIS Competitors
Pro9 other drugs also target MET. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (MET). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to EMRELIS
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EMRELIS FDA Label Details
ProIndications & Usage
FDA Label (PDF)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 ] , 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 ] . Continued approval for this indication may be contingent upon verification and description of clinical ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.