Tisotumab vedotin
Also known as Tivdak, Tisotumab vedotin-tftv
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
Approved
BLA761208,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- Seagen Inc. Source: Company record for Seagen Inc. (opens in a new tab)
- Indication
- Cervical Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- BLA 761208 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761208 (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 22 Feb 20211 linked trial
- Filed Completed
- Approved Current stageFirst approval 20 Sep 2021
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 Tisotumab vedotin. Editors add each one with its source.
Filed application
No filed application is on record for Tisotumab vedotin. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Tisotumab vedotin.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT04697628ClinicalTrials.gov record for NCT04697628 (opens in a new tab)innovaTV 301 | Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer | Phase 3 | Completed | 502 (actual) | 24 Jul 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04697628 (opens in a new tab) |
Posted results on ClinicalTrials.gov for innovaTV 301
Serious adverse events (For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months)): Tisotumab Vedotin 82 of 250; Chemotherapy 94 of 239 Source: ClinicalTrials.gov results for NCT04697628 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing innovaTV 301 (3), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
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 |
|---|---|---|---|---|---|
| BLA761208Action letter for BLA761208 (opens in a new tab) | Supplement 7 Efficacy | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) | |
| BLA761208Action letter for BLA761208 (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)
Authorised
Tivdak (EMEA/H/C/005363)
- Authorised
- Therapeutic area
- Uterine Cervical Neoplasms
- Marketing authorisation holder
- Genmab A/S
- Active substance (INN)
- tisotumab vedotin
- ATC code
- L01FX23
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Tivdak (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 761208 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT04697628 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA BLA761208 (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.