FDA to Evaluate Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

A biologics license application (BLA) has been submitted to the FDA for the accelerated approval of the antibody-drug conjugate (ADC) tisotumab vedotin for use in patients with recurrent or metastatic cervical cancer that has progressed on or following chemotherapy.¹ The application is based on data from the phase 2 innovaTV 204 trial (NCT03438396), in which the ADC induced an objective response rate (ORR) of 24% (95% CI, 15.9%-33.3%) in patients with recurrent or metastatic cervical cancer who previously received doublet chemotherapy and bevacizumab (Avastin).²

The ORR included a complete response rate of 7%, a partial response rate of 17%, and a median duration of response (DOR) of 8.3 months (95% CI, 4.2—not reached). Moreover, the median time to response (TTR) with tisotumab vedotin was 1.4 months (range, 1.1-5.1) with activity reported within the first 2 treatment cycles.

“The BLA submission is an important step toward our goal of improving the lives of women with recurrent or metastatic cervical cancer,” Jan van de Winkel, PhD, chief executive officer of Genmab, stated in a press release. “We believe, if approved, tisotumab vedotin as monotherapy has the potential to become an important treatment option for women with recurrent or metastatic cervical cancer, who have disease progression on or after chemotherapy.”

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