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Tivdak (tisotumab-vedotin)
Tisotumab vedotin is a tissue factor (TF)-directed antibody drug conjugate that targets and disrupts microtubule networks in cancer cells.
At a glance
| Generic name | tisotumab-vedotin |
|---|---|
| Sponsor | SEAGEN |
| Drug class | Antibody-drug conjugate |
| Target | Tissue factor |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2021 |
| Annual revenue | 147 |
Mechanism of action
Tisotumab vedotin works by binding to tissue factor on the surface of cancer cells. This binding triggers the internalization of the drug-conjugate complex, which is then released into the cell. The released component, monomethyl auristatin E (MMAE), disrupts the microtubule network, leading to cell cycle arrest and apoptotic cell death. This mechanism of action is distinct from traditional chemotherapy agents and offers a new approach to treating cancer.
Approved indications
- Recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
Boxed warnings
- 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 )
Common side effects
- Peripheral neuropathy
- Conjunctival adverse reactions
- Nausea
- Fatigue
- Aspartate aminotransferase increased
- Epistaxis
- Alopecia
- Alanine aminotransferase increased
- Hemorrhage
- Hemoglobin decreased
- Peripheral neuropathy
- Ocular adverse reactions
Drug interactions
- Strong CYP3A4 Inhibitors
Key clinical trials
- 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) (PHASE3)
- Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (PHASE2)
- Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer (PHASE1, PHASE2)
- Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer (PHASE4)
- Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (PHASE3)
- To Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies (PHASE1)
- A Trial of Tisotumab Vedotin in Cervical Cancer (PHASE2)
- A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tivdak CI brief — competitive landscape report
- Tivdak updates RSS · CI watch RSS
- SEAGEN portfolio CI