EMRELIS (telisotuzumab vedotin-tllv)
EMRELIS is indicated for the treatment of Non-Small Cell Lung Cancer.
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.
Development Insights
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 Target & Pathway
ProTarget
EMRELIS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in EMRELIS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications EMRELIS treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to EMRELIS
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04928846 | M18-868 2023-505749-14-00 | Ph 3 | recruiting | A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC) |
| NCT07323641 | 25-2145 NCI-2025-09155 | Ph 2 | recruiting | Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer |
| NCT06568939 | M25-274 | Ph 2 | recruiting | A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC) |
| NCT03539536 | M14-239 2023-507902-15-00 | Ph 2 | active not recruiting | Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer |
| NCT05513703 results posted | M22-137 2022-500608-23-00 | Ph 2 | terminated | A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) |
| NCT02099058 | M14-237 2014-003154-14 | Ph 1 | active not recruiting | A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors |
| NCT06093503 | M22-142 2022-502283-20-00 | Ph 3 | withdrawn | Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein |
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
Indications & Usage
FDA Label (PDF)EMRELIS is indicated for the treatment of Non-Small Cell Lung Cancer.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment