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Tivdak FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 21, 2021.

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. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • 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 fatigue, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival adverse reactions, hemorrhage, dry eye, diarrhea, rash, and laboratory abnormalities.

Development timeline for Tivdak

DateArticle
Sep 20, 2021Approval FDA Grants Accelerated Approval for Tivdak (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer
Apr  9, 2021Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer
Feb 10, 2021Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer
Jun 29, 2020Genmab Announces Very Favorable Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer
Jun 16, 2017Genmab Announces Preliminary Cervical Cancer Data from Tisotumab Vedotin Phase I/II Study

Further information

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