Recurrent cervical cancer that progresses after chemotherapy has had few effective options, and tissue factor is unusually highly expressed in these tumors. Tivdak (tisotumab vedotin) exploited that.
Tisotumab vedotin was the first tissue factor-directed therapy approved, delivering the microtubule-disrupting agent MMAE into tumor cells after binding and internalization. The intravenous conjugate treats adults with recurrent or metastatic cervical cancer that progressed on or after chemotherapy.
Tivdak’s accelerated approval converted to full approval in 2024 on confirmatory overall survival data from innovaTV 301, removing its main regulatory overhang. With no biosimilar competition and a distinctive target, it is the reference second-line cervical cancer agent.
