Seagen + Genmab A/S submit tisotumab vedotin BLA to the FDA for patients with recurrent or metastatic cervical cancer.

-- Seagen Inc. and Genmab A/S 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. The submission is based on the results of the innovaTV 204 pivotal phase II single-arm clinical trial evaluating tisotumab vedotin as monotherapy in this setting. The topline results from the phase II study were announced in June 2020 and data were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 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.