Telisotuzumab vedotin
Also known as Emrelis, Telisotuzumab vedotin-tllv
AbbVie Inc. ABBV · Non Small Cell Lung Cancer; Non-Small Cell Lung Cancer; c-MET
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
2
From ClinicalTrials.gov
Latest FDA action
Approved
BLA761384,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- AbbVie Inc. ABBV Source: Company record for AbbVie Inc. (opens in a new tab)
- Indications
- Non Small Cell Lung Cancer; Non-Small Cell Lung Cancer; c-MET Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- BLA 761384 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761384 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 25 Mar 20222 linked trials
- Filed Completed
- Approved Current stageFirst approval 14 May 2025
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Telisotuzumab vedotin. Editors add each one with its source.
Filed application
No filed application is on record for Telisotuzumab vedotin. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Telisotuzumab vedotin.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06093503ClinicalTrials.gov record for NCT06093503 (opens in a new tab) | 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That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein | Phase 3 | Withdrawn | 0 (actual) | 11 Apr 2028 (estimated) | No |
| NCT04928846ClinicalTrials.gov record for NCT04928846 (opens in a new tab) | 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) | Phase 3 | Recruiting | 768 (estimated) | Dec 2028 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| BLA761384Action letter for BLA761384 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Telisotuzumab vedotin.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 761384 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06093503 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04928846 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA BLA761384 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.