Tisotumab vedotin (Tivdak)
Mechanism of action
From the NCI Drug Dictionary: An antibody-drug conjugate (ADC) comprised of a monoclonal antibody against human tissue factor (TF) covalently coupled, via a protease-cleavable peptide linker, to monomethyl auristatin E (MMAE), an auristatin derivative and potent microtubule disrupting agent, with potential antiangiogenic, anticoagulant and antineoplastic activities. Upon administration, tisotumab vedotin binds to cell surface TF and is internalized. The antibody moiety prevents binding of TF to factor VIIa (FVIIa) and interferes with the activation of factor X (FX) into FXa. This may prevent thrombin formation and cancer-associated venous thromboembolism, and may inhibit angiogenesis and tumor cell proliferation. After internalization of the agent, the MMAE moiety is released by proteolytic cleavage. It then binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and apoptosis.
Diseases for which it is used
History of changes in FDA indication
- 2021-09-20: Granted accelerated approval for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. (Based on innovaTV 204)
- 2024-04-24: Granted regular approval for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. (Based on innovaTV 301)
Also known as
- Code name: HuMax-TF-ADC
- Generic name: tisotumab vedotin-tftv
- Brand name: Tivdak