Tisotumab vedotin

Overview

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. It is administered by infusion into a vein.[1] WP

Tisotumab vedotin was approved for medical use in the United States in September 2021, and in the European Union in March 2025. The US Food and Drug Administration considers it to be a first-in-class medication.[1–5] WP

Drug class

Antineoplastic WP

From the Wikipedia article's infobox.

Risks and side effects

Adverse effects

In the United States, Tivdak carries a boxed warning for ocular toxicity, which occurs in up to 60% of treated patients. In clinical trials, the most common forms of ocular toxicity were dry eye, conjunctivitis, corneal damage, and blepharitis.[1] WP

Other common adverse effects include bleeding (occurring in approximately 60% of patients, most often nosebleed) and peripheral neuropathy (42% of patients). Like all drugs containing MMAE, tisotumab vedotin can cause inflammation of the lungs.[1] WP

Pharmacology

Mechanism of action

The antibody portion of tisotumab vedotin (tisotumab) binds to and forms a complex with tissue factor, a molecule expressed on the surface of cancer cells. This complex is then taken up into the cell, where tisotumab vedotin is broken down by proteolytic cleavage, releasing MMAE, which stops the cell cycle and kills the cell by apoptosis.[1] WP

History

History

Tisotumab vedotin was developed by Genmab in Utrecht, the Netherlands, and Copenhagen, Denmark, with the code name TF-011-MMAE. In September 2021, tisotumab vedotin was granted accelerated approval by United States Food and Drug Administration for the use of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.[6][7] WP

Legal status

Legal status

In April 2024, tisotumab vedotin was granted traditional approval by the US Food and Drug Administration (FDA) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin previously received accelerated approval for this indication.[8] WP

In January 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Tivdak, intended for the treatment of recurrent or metastatic cervical cancer. The applicant for this medicinal product is Pfizer Europe MA EEIG. Tisotumab vedotin was authorized for medical use in the European Union in March 2025.[3][4] WP

Names

Tisotumab vedotin is the international nonproprietary name. Tivdak is the brand name for tisotumab vedotin in the United States.[2][9] WP

Chemistry

Harm reduction information

No harm reduction data is on file for this compound yet. That means no dose, timing or combination data from PsychonautWiki or TripSit. Please don't guess a dose from similar compounds. If you have taken it and feel unwell, contact emergency services or a poison control center.

User reports

Pop culture

No references added yet.

Sources

1. Journal / agency Tivdak- tisotumab vedotin injection, powder, for solution
2. Other Seagen and Genmab Announce FDA Accelerated Approval for Tivdak (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer. 20 September 2021
3. Journal / agency Tivdak EPAR. 30 January 2025
4. Other Tivdak. 31 March 2025
5. Journal / agency Advancing Health Through Innovation: New Drug Therapy Approvals 2021. 13 May 2022
6. Journal / agency Breij EC, de Goeij BE, Verploegen S, Schuurhuis DH, Amirkhosravi A, Francis J, Miller VB, Houtkamp M, Bleeker WK, Satijn D, Parren PW. An antibody-drug conjugate that targets tissue factor exhibits potent therapeutic activity against a broad range of solid tumors. Cancer Res. February 2014. doi:10.1158/0008-5472.CAN-13-2440 · PMID 24371232
7. Journal / agency Research, Center for Drug Evaluation and. FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer. FDA. 22 September 2021
8. Journal / agency FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer. 29 April 2024
9. Journal / agency World Health Organization. International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 75. WHO Drug Information. 2016

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