Drugs / Telisotuzumab Vedotin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | non-small cell lung carcinoma | 2024-09-27 | “submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of telisotuzumab vedotin (Teliso-V)” abbvie.com ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03311477 | Nov 2017 → Mar 2019 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT02099058 | Jan 2014 → Aug 2026 overdue | — | AbbVie | Active not recruiting | No outcome recorded |
| Phase 25 trials · 1 missed | ||||||
| Phase 2 | NCT07323641 | Feb 2026 → Feb 2027 expected | non-small cell lung carcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06568939 | Jan 2025 → Feb 2028 expected | non-small cell lung carcinoma | AbbVie | Recruiting | No outcome recorded |
| Phase 2 | NCT05513703 | Nov 2022 → Oct 2024 | non-small cell lung carcinoma | AbbVie | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03539536 | Oct 2018 → Jul 2026 overdue | non-small cell lung carcinoma | AbbVie | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03574753 | Mar 2018 → Dec 2019 | squamous cell lung carcinoma | SWOG Cancer Research Network | Completed | Missed primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT06093503 | May 2024 → Apr 2028 | non-small cell lung carcinoma | AbbVie | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04928846 | Mar 2022 → Dec 2028 expected | non-small cell lung carcinoma | AbbVie | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT04830202 Background | — | non-small cell lung carcinoma | AbbVie | Temporarily not available | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-08-21 | AbbVie | Results AbbVie to Present New Data at WCLC 2026 Showcasing Innovation Across Lung Cancer Pipeline abbvie.com ↗
Telisotuzumab vedotin Demonstrates Potent Antitumor Efficacy in Preclinical Models of Diffuse Pleural Mesothelioma |
| 2025-05-14 | AbbVie | Regulatory U.S. FDA Approves EMRELIS™ (telisotuzumab vedotin-tllv) for Adults With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) With High c-Met Protein Overexpression abbvie.com ↗ |
| 2024-09-27 | AbbVie | Regulatory AbbVie Submits Biologics License Application to the FDA for Telisotuzumab Vedotin (Teliso-V) in Previously Treated Non-Small Cell Lung Cancer abbvie.com ↗
Biologics License Application (BLA) submission for accelerated approval is supported by data from the Phase 2 LUMINOSITY trial (M14-239). |
| 2023-11-29 | AbbVie | Results AbbVie Announces Positive Topline Results from Phase 2 LUMINOSITY Trial Evaluating Telisotuzumab-Vedotin (Teliso-V) for Patients with Previously Treated Non-Small Cell Lung Cancer (NSCLC) abbvie.com ↗
AbbVie (NYSE: ABBV) announced today topline results from the single-arm Phase 2 LUMINOSITY trial evaluating telisotuzumab-vedotin (Teliso-V) in patients with c-Met protein overexpression, epidermal growth factor receptor (EGFR) wild type, advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC). |
| 2022-01-04 | AbbVie | Regulatory AbbVie Announces U.S. FDA Granted Breakthrough Therapy Designation (BTD) to Telisotuzumab Vedotin (Teliso-V) for Previously Treated Non-Small Cell Lung Cancer abbvie.com ↗
AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to investigational telisotuzumab vedotin (Teliso-V) for the treatment of patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy. |
All press releases naming this drug 5 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Telisotuzumab vedotin | “A Phase II Study of Telisotuzumab Vedotin in Patients With c-MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753).” PMID 33221175 ↗ Oct 20209“Telisotuzumab vedotin (formerly ABBV-399) is an antibody-drug conjugate targeting c-Met-overexpressing tumor cells, irrespective of MET gene amplification status.” PMID 33675179 ↗ Mar 2021 |
| Known as | ABBV-399 | “Telisotuzumab vedotin (formerly ABBV-399) is an antibody-drug conjugate targeting c-Met-overexpressing tumor cells, irrespective of MET gene amplification status.” PMID 33675179 ↗ Mar 2021 |
| Known as | Teliso-V | “Telisotuzumab vedotin (Teliso-V) is a c-Met-directed antibody-drug conjugate with a monomethyl auristatin E cytotoxic payload.” PMID 38843488 ↗ Jun 20241“Telisotuzumab vedotin (Teliso-V) is an anti-c-Met-directed antibody-drug conjugate.” PMID 34426443 ↗ Aug 2021 |
| Known as | telisotuzumab | “telisotuzumab vedotin is a monoclonal antibody, called telisotuzumab, linked to a toxic agent, called vedotin.” NCT07323641 ↗ |
| Action | Deplete | “delivers vedotin to kill them” NCT07323641 ↗ |
| Modality | Monoclonal antibody | “an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE)” NCT03574753 ↗ |
| Route | Intravenous | “During dose escalation, patients received Teliso-V monotherapy intravenously once every 3 weeks (0.15-3.3 mg/kg) or once every 2 weeks (1.6-2.2 mg/kg).” PMID 34426443 ↗ Aug 2021 |
| Target | MET | “targeting c-Met-overexpressing tumor cells, irrespective of MET gene amplification status.” PMID 33675179 ↗ Mar 2021 |