Drug · Adc
Tisotumab Vedotin
CI-DRUG-00000804Explore in graph →CHEMBL4297841 Approved
Regulatory
Approvals (3)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
emaProvenance
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | Malignant Cervical Neoplasm | Tivdak as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy (see section 5.1). | approved | Mar 28, 2025 | ema |
| US FDA | — | Efficacy supplement 2024-04-29 (see label) | approved | Apr 29, 2024 | openfda |
| US FDA | Malignant Cervical Neoplasm | TIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. ( 1 ) | approved | Sep 20, 2021 | openfda |
Data updated 4 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 4 | 1 | 2 | 13 | 3 | EU, US | Sep 20, 2021 | Nov 30, 2013 |
| Malignant Cervical Neoplasm | Approved | Phase 4 | 2 | 1 | 2 | 5 | 2 | EU, US | Sep 20, 2021 | Jun 12, 2018 |
| Malignant Lung Neoplasm | Phase2 | Phase 2 | 1 | 0 | 0 | 4 | 0 | — | — | Nov 30, 2013 |
| Malignant Vulvar Neoplasm | Phase2 | Phase 2 | 1 | 0 | 0 | 1 | 0 |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
No curated evidence item mentions this therapy yet.
Clinical trials
Trials with this intervention (13)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT06952660 | Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer | recruiting | Phase 4 | 100 | PfizerINDUSTRY | 2 | Sep 25, 2026 | clinicaltrials |
| NCT06459180 | A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) |