Chemistry:Tisotumab vedotin
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | Tissue factor (TF) |
| Clinical data | |
| Trade names | Tivdak |
| Other names | Tisotumab vedotin-tftv |
| License data | |
| Pregnancy category |
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| Routes of administration | Intravenous |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Protein binding | 68–82% (MMAE) |
| Metabolism | Hepatic, by CYP3A4 (MMAE) |
| Metabolites | MMAE |
| Elimination half-life | 4 days |
| Excretion | Fecal, renal (MMAE) |
| Identifiers | |
| CAS Number | |
| UNII | |
| KEGG | |
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][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.[1] In clinical trials, the most common forms of ocular toxicity were dry eye, conjunctivitis, corneal damage, and blepharitis.[1]
Other common adverse effects include bleeding (occurring in approximately 60% of patients, most often nosebleed) and peripheral neuropathy (42% of patients).[1] Like all drugs containing MMAE, tisotumab vedotin can cause inflammation of the lungs.[1]
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]
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
Names
Tisotumab vedotin is the international nonproprietary name.[6] Tivdak is the brand name for tisotumab vedotin in the United States.[2]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 "Tivdak- tisotumab vedotin injection, powder, for solution". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9fe3f32-4219-466e-acb9-3f609b4f4df1.
- ↑ 2.0 2.1 "Seagen and Genmab Announce FDA Accelerated Approval for Tivdak (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer". Seagen. 20 September 2021. https://www.businesswire.com/news/home/20210920005921/en/.
- ↑ (PDF) Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (Report). 13 May 2022. https://www.fda.gov/media/155227/download. Retrieved 22 January 2023.
This article incorporates text from this source, which is in the public domain.
- ↑ "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. doi:10.1158/0008-5472.CAN-13-2440. PMID 24371232.
- ↑ Research, Center for Drug Evaluation and (2021-09-22). "FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer" (in en). FDA. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 75". WHO Drug Information 30 (1): 159–60. 2016.
External links
- "Tisotumab vedotin". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/tisotumab%20vedotin.
- Clinical trial number NCT03438396 for "A Trial of Tisotumab Vedotin in Cervical Cancer" at ClinicalTrials.gov
- Clinical trial number NCT03245736 for "Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors" at ClinicalTrials.gov
- Clinical trial number NCT02001623 for "Tisotumab Vedotin (HuMax-TF-ADC) Safety Study in Patients With Solid Tumors" at ClinicalTrials.gov
- Clinical trial number NCT02552121 for "Tisotumab Vedotin (HuMax-TF-ADC) Safety Study in Patients With Solid Tumors" at ClinicalTrials.gov
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