The First Antibody-drug Conjugate Therapy for Cervical Cancer Resistant to Chemotherapy 

THE FDA GRANTED ACCELERATED APPROVAL TO A NEW THERAPY FOR ADVANCED CERVICAL CANCER 

The U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv (Tidvak) for patients with cervical cancer that has come back or spread during or after treatment with chemotherapy. It is the first antibody-drug based therapeutic for this patient population. 

Tisotumab vedotin-tftv is an intravenous medication that works in multiple ways. It contains the tisotumab antibody that binds to a protein called tissue factor, which is found on some cancer cells, to help prevent them from growing and stop the development of blood vessels that support tumor growth. In the new treatment, tisotumab is coupled to a medication that may kill cancer cells.  

The FDA based the approval decision on response data from an open-label, multicenter, single-arm clinical trial. The study evaluated the efficacy of the medication in 101 patients with cervical cancer that had recurred or spread despite treatment with up to two prior chemotherapy regimens, including at least one platinum-based chemotherapy. The overall response rate after treatment was 24 percent, with a median duration of response time of 8.3 months.   

The FDA approval came with a boxed warning to advise health professionals of the risk of ocular toxicity.  

It was estimated that 14,480 new cases of cervical cancer would be diagnosed in the U.S. in 2021.  

The FDA rendered the decision on September 20, 2021. Accelerated approval means continued approval may be contingent upon a confirmatory trial.