Targeted Therapy for Advanced Cervical Cancer Receives Full Approval
Tisotumab vedotin-tftv is approved to treat certain recurrent or metastatic cervical cancers.
The U.S. Food and Drug Administration (FDA) has approved tisotumab vedotin-tftv (Tivdak) for patients with recurrent or metastatic cervical cancer whose disease progressed during or after prior chemotherapy.
Tisotumab vedotin-tftv is an antibody-drug conjugate, a type of targeted therapy that uses an antibody to selectively deliver toxic drugs to cancer cells. In this case, the antibody binds a protein called tissue factor that is often highly expressed on the surface of cervical cancer cells. The development of tisotumab vedotin-tftv and early clinical testing were reported in the AACR journals Cancer Research and Clinical Cancer Research, respectively.
It was previously granted accelerated approval for the same indication in September 2021.
The conversion to a full approval was based on results from innovaTV 301, an open-label, active-controlled, multicenter, randomized phase III clinical trial. The trial enrolled 502 patients with recurrent or metastatic cervical cancer who had been previously treated with one or two systemic therapies, including chemotherapy with or without bevacizumab (Avastin) and/or a PD-1/PD-L1-targeted immunotherapy. Patients were randomly assigned (1:1) to receive tisotumab vedotin-tftv or investigator’s choice of chemotherapy.
Patients treated with tisotumab vedotin-tftv had a longer median overall survival than those treated with chemotherapy (11.5 months vs. 9.5 months). Among patients in the tisotumab vedotin-tftv arm, 17.8% experienced a response to treatment, compared with 5.2% of patients who had a response to chemotherapy.
The recommended dose is 2 mg/kg (up to 200 mg) delivered intravenously over 30 minutes every three weeks until disease progression or unacceptable toxicity.
The prescribing information includes a boxed warning for severe ocular toxicities.
Cervical cancer is a slow-growing cancer that develops in the cervix. Most cases of cervical cancer are caused by human papillomavirus (HPV) infection. According to federal statistics, it was estimated that 13,820 individuals would be diagnosed with cervical cancer and 4,360 patients would die of the disease in the United States in 2024.
The FDA rendered its decision on April 29, 2024.
