Genmab and Seagen have announced the submission of a Biologics License Application (BLA) to the FDA seeking accelerated approval for tisotumab vedotin.

This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

“This BLA submission is an important step toward our goal of improving the lives of women with recurrent or metastatic cervical cancer,” says Jan van de Winkel, Chief Executive Officer of Genmab. “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.”

Based on the innovaTV 204 trial

The submission is based on the results of the innovaTV 204 phase 2 single-arm clinical trial evaluating tisotumab vedotin as monotherapy in this setting. The results from the phase 2 study were announced in June 2020.

Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell-surface protein expressed on multiple solid tumors including cervical cancer and is associated with tumor growth, angiogenesis, metastasis and poor prognosis.

Photo of Jan van de Winkel. Image courtesy of Genmab, All rights reserved. © 2021 Genmab A/S