Tisotumab vedotin explained

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.

Tisotumab vedotin was approved for medical use in the United States in September 2021.^[2] The U.S. Food and Drug Administration considers it to be a first-in-class medication.^[3]

Adverse effects

In the United States, Tivdak carries a black box 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.

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.

Mechanism of action

See main article: Antibody-drug conjugate. 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.

History

Tisotumab vedotin was developed by Genmab in Utrecht, the Netherlands, and Copenhagen, Denmark, with the code name TF-011-MMAE.^[4] 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.^[5]

Society and culture

Legal status

In April 2024, Tisotumab vedotin was granted traditional approval for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin previously received accelerated approval for this indication.^[6]

Names

Tisotumab vedotin is the international nonproprietary name.^[7] Tivdak is the brand name for tisotumab vedotin in the United States.

External links

• Web site: Tisotumab vedotin . U.S. National Library of Medicine . Drug Information Portal .

Notes and References

1. Web site: Tivdak- tisotumab vedotin injection, powder, for solution . DailyMed . 31 October 2021.
2. Web site: Seagen and Genmab Announce FDA Accelerated Approval for Tivdak (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer . Seagen . Business Wire . 20 September 2021 . 20 September 2021.
3. Advancing Health Through Innovation: New Drug Therapy Approvals 2021 . U.S. Food and Drug Administration (FDA) . 13 May 2022 . PDF . 22 January 2023 . 6 December 2022 . https://web.archive.org/web/20221206210020/https://www.fda.gov/media/155227/download . live .
4. Breij EC, de Goeij BE, Verploegen S, Schuurhuis DH, Amirkhosravi A, Francis J, Miller VB, Houtkamp M, Bleeker WK, Satijn D, Parren PW . 6 . An antibody-drug conjugate that targets tissue factor exhibits potent therapeutic activity against a broad range of solid tumors . Cancer Res . 74 . 4 . 1214–26 . February 2014 . 24371232 . 10.1158/0008-5472.CAN-13-2440. 10230916 . free .
5. Research . Center for Drug Evaluation and . 22 September 2021 . FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer . FDA . en.
6. Web site: FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer . . 29 April 2024 . 29 April 2024.
7. ((World Health Organization)) . 2016 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 75 . WHO Drug Information . 30 . 1 . 159–60 . 10665/331046 . free . World Health Organization .