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Tisotumab vedotin information


Tisotumab vedotin
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetTissue factor (TF)
Clinical data
Trade namesTivdak
Other namesTisotumab vedotin-tftv
License data
  • US DailyMed: Tisotumab vedotin
Pregnancy
category
  • Contraindicated[1]
Routes of
administration
Intravenous
Drug classAntineoplastic
ATC code
  • L01FX23 (WHO)
Legal status
Legal status
  • US: WARNING[2]Rx-only[1]
Pharmacokinetic data
Protein binding68–82% (MMAE)
MetabolismLiver, by CYP3A4 (MMAE)
MetabolitesMMAE
Elimination half-life4 days
ExcretionFecal, renal (MMAE)
Identifiers
CAS Number
  • 1418731-10-8
UNII
  • T41737F88A
KEGG
  • D11814

Tisotumab vedotin, sold under the brand name Tivdak, is an antibody-drug conjugate used to treat cervical cancer.[1] It is a combination of tisotumab, a monoclonal antibody against tissue factor, and monomethyl auristatin E (MMAE), a potent inhibitor of cell division. It is administered by infusion into a vein.[1]

Tisotumab vedotin was approved for medical use in the United States in September 2021.[1][3] The U.S. Food and Drug Administration considers it to be a first-in-class medication.[4]

  1. ^ a b c d e "Tivdak- tisotumab vedotin injection, powder, for solution". DailyMed. Retrieved 31 October 2021.
  2. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  3. ^ "Seagen and Genmab Announce FDA Accelerated Approval for Tivdak (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer". Seagen. 20 September 2021. Retrieved 20 September 2021 – via Business Wire.
  4. ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. Public Domain This article incorporates text from this source, which is in the public domain.

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