Tivdak FDA Approval History
Last updated by Judith Stewart, BPharm on May 1, 2024.
FDA Approved: Yes (First approved September 20, 2021)
Brand name: Tivdak
Generic name: tisotumab vedotin-tftv
Dosage form: Lyophilized Powder for Injection
Company: Seagen Inc.
Treatment for: Cervical Cancer
Tivdak (tisotumab vedotin-tftv) is a tissue factor-directed antibody and microtubule inhibitor conjugate for the treatment of patients with recurrent or metastatic cervical cancer.
- Tivdak is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
- Tissue factor is a protein expressed on cervical cancer cells that can promote tumor growth, angiogenesis and metastases. Tivdak is a first-in-class antibody-drug conjugate (ADC) that targets tissue factor to induce cancer cell death.
- Tivdak is administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.
- Tivdak can cause serious adverse reactions including peripheral neuropathy, hemorrhage, and pneumonitis. The Tivdak product label carries a boxed warning for ocular toxicity that can lead to severe vision loss and corneal ulceration.
- Common side effects include peripheral neuropathy, conjunctival adverse reactions, nausea, fatigue, epistaxis, alopecia, and hemorrhage.
Common laboratory abnormalities include decreased hemoglobin, increased aspartate aminotransferase, and increased alanine aminotransferase.
Development timeline for Tivdak
Further information
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