SGEN - Genmab and Seagen submit tisotumab vedotin BLA to the FDA

Genmab (GMAB) and Seagen (SGEN) announce the submission of a Biologics License Application ((BLA)) to the U.S. FDA seeking accelerated approval for tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.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.The submission is based on the results of the innovaTV 204 pivotal phase 2 single-arm clinical trial evaluating tisotumab vedotin as monotherapy in this setting.The innovaTV 204 trial is an ongoing single-arm, global, multicenter study, which tested the treatment in 101 patients at multiple centers in the U.S. and Europe.

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Genmab and Seagen submit tisotumab vedotin BLA to the FDA