SGEN - FDA accepts Genmab Seagen's tisotumab vedotin BLA application for review

Genmab A/S (GNMSF) and Seagen (SGEN) announces that the U.S. FDA has accepted for Priority Review the Biologics License Application ((BLA)) 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 FDA has set a target action date of Oct 10, 2021.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 BLA submission is based on the results of the innovaTV 204 pivotal phase 2 single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent or metastatic cervical cancer.

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FDA accepts Genmab, Seagen's tisotumab vedotin BLA application for review