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Tisotumab Vedotin (tivdak)
Tisotumab vedotin, sold under the brand name Tivdak, is an antibody-drug conjugate used to treat cervical cancer. It is a combination of tisotumab, a monoclonal antibody against tissue factor, and monomethyl auristatin E (MMAE), a potent inhibitor of cell division. Tisotumab vedotin is administered by infusion into a vein. The drug targets tissue factor, a primary initiator of the extrinsic blood coagulation cascade. This mechanism leads to the disruption of the microtubule network in actively dividing cells, resulting in cell cycle arrest and apoptotic cell death. Tisotumab vedotin has shown clinical differentiation in treating recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The commercial significance of this drug is its potential to provide a new treatment option for patients with limited therapeutic alternatives.
At a glance
| Generic name | tivdak |
|---|---|
| Sponsor | SEAGEN |
| Drug class | Antibody-Drug Conjugate (ADC) |
| Target | Tissue factor |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2021 |
| Annual revenue | 147 |
Approved indications
- Treatment of adult patients with 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 P
Common side effects
- Hemoglobin decreased
- Peripheral neuropathy
- Conjunctival adverse reactions
- Nausea
- Fatigue
- Aspartate aminotransferase increased
- Epistaxis
- Alopecia
- Alanine aminotransferase increased
- Hemorrhage
- Sodium decreased
- Constipation
Serious adverse events
- Serious adverse reactions (overall)
- Urinary tract infection
- Small intestinal obstruction
- Sepsis
- Abdominal pain
- Hemorrhage
- Acute kidney injury
- Pneumonia
- Stevens-Johnson syndrome
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:
- Tisotumab Vedotin CI brief — competitive landscape report
- Tisotumab Vedotin updates RSS · CI watch RSS
- SEAGEN portfolio CI