Tisotumab Vedotin: First Approval

Tisotumab vedotin (Tivdak™) is an antibody-drug conjugate comprising a fully human monoclonal antibody specific for tissue factor (TF-011) conjugated to monomethyl auristatin E (MMAE) that has been engineered to target tissue factor expressing tumours. Based on the results of a phase II trial, tisotumab vedotin has been granted accelerated approval in the USA for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This article summarizes the milestones in the development of tisotumab vedotin leading to this first approval.