Last reviewed 2026-04-20 · How we verify

Tivdak (TISOTUMAB)

Tivdak works by binding to a specific target on cancer cells, triggering an immune response to destroy the cancer.

At a glance

Mechanism of action

Tisotumab vedotin-tftv is a tissue factor (TF)-directed antibody drug conjugate (ADC). The antibody is a human IgG1 directed against cell surface TF. TF is the primary initiator of the extrinsic blood coagulation cascade. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease-cleavable linker. Nonclinical data suggests that the anticancer activity of tisotumab vedotin-tftv is due to the binding of the ADC to TF expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin-tftv also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

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

• Hemoglobin decreased
• Peripheral neuropathy
• Conjunctival adverse reactions
• Nausea
• Fatigue
• Aspartate aminotransferase increased
• Epistaxis
• Alopecia
• Alanine aminotransferase increased
• Hemorrhage
• Urinary tract infection
• Small intestinal obstruction

Drug interactions

• Strong CYP3A4 Inhibitors
• 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.

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