FDA Approval of Tisotumab Vedotin for Recurrent or Metastatic Cervical Cancer


A brief review of the FDA approval and implications of tisotumab vedotin in patients with recurrent or metastatic cervical cancer.


Rebecca Arend, MD, MPH: I’d like to highlight the recent FDA approval of tisotumab vedotin, or TV. Tivdak is a tissue factor–directed antibody, and microtubular inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Women with recurrent cervical cancer is truly a very high unmet need. There’s no standard of care after progression on first-line treatment. Based on the overall response rate of TV [tisotumab vedotin] of 24% with 7 complete responses, 17 partial responses, and a median duration of response of 8.3 months, TV [tisotumab vedotin] is truly going to be the new standard of care in this population. Additionally, its efficacy is supported by a median progression-free survival of 4.2 months and an overall survival of 12.1 months.

Possibly in this population even more important than these numbers is the disease control rate of 72%. The fact that there’s a rapid response in tumor burden is critical for controlling the progression of this population of patients with a very poor prognosis.

Transcript edited for clarity.

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