TIVDAK (tisotumab vedotin-tftv) · SEAGEN
TIVDAK (tisotumab vedotin-tftv) is a tissue factor-directed antibody and microtubule inhibitor conjugate. It is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer. This therapy is specifically intended for patients who have experienced disease progression on or after chemotherapy.
How TIVDAK Works
Tisotumab vedotin-tftv is an antibody-drug conjugate (ADC) that targets cell surface tissue factor (TF). Upon binding to TF-expressing cancer cells, the ADC is internalized and releases MMAE, a microtubule-disrupting agent, via proteolytic cleavage. This process disrupts the microtubule network within actively dividing cells, resulting in cell cycle arrest and apoptotic cell death.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-09-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TIVDAK Approval History
What TIVDAK Treats
1 indicationsTIVDAK is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cervical Cancer
TIVDAK Boxed Warning
OCULAR TOXICITY • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. [see Warnings and Precautions (5.1) ]. • Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. [see Dosage and Administration (2.2) and Warnings and Precaution...
WARNING: OCULAR TOXICITY • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. [see Warnings and Precautions (5.1) ]. • Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . • Adhere to the required premedication and eye care before, during, and after infusion. [see Dosage and Administration (2.2) ]. • Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ]. WARNING: OCULAR TOXICITY See full prescribing information for complete boxed warning. • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss and corneal ulceration. ( 5.1 ) • Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. ( 2.2 , 5.1 ) • Adhere to the required premedication and eye care before, during, and after infusion. ( 2.2 ) • Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity. ( 2.3 , 5.1 )
TIVDAK Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 TIVDAK's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TIVDAK treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TIVDAK
3 of 11FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
SEAGEN's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06459180 | 2870-020 MK-2870-020, TroFuse-020 | Ph 3 | active not recruiting | 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) |
| NCT06952660 | C5721005 | Ph 4 | recruiting | Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer |
| NCT03485209 innovaTV 207 | SGNTV-001 C5721001; innovaTV 207, 2023-503812-34-00 | Ph 2 | active not recruiting | Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors |
| NCT03786081 | GCT1015-05 InnovaTV 205, MK-3475-834 | Ph 1, Ph 2 | terminated | Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer |
| NCT04697628 innovaTV 301 results posted | SGNTV-003 C5721002, 2023-503813-31-01 | Ph 3 | completed | Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer |
| NCT05866354 | ZL-1309-002 | Ph 1 | completed | To Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies |
| NCT03438396 results posted | GCT1015-04 innovaTV 204 | Ph 2 | completed | A Trial of Tisotumab Vedotin in Cervical Cancer |
| NCT03657043 results posted | SGNTV-002 | Ph 2 | completed | A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208) |
| NCT03913741 innovaTV 206 | GCT1015-06 JapicCTI-194639 | Ph 1, Ph 2 | completed | A Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies |
| NCT03245736 results posted | GCT1015-03 | Ph 2 | completed | Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors. |
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.
TIVDAK FDA Label Details
Indications & Usage
FDA Label (PDF)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.
WARNING: OCULAR TOXICITY • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. [see Warnings and Precautions (5.1) ]. • Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exa...
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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