Genmab and Seagen submit tisotumab vedotin BLA to FDA
Danish biotech firm Genmab (OMX: GEN) and Swiss firm Seagen (Nasdaq: SGEN) have filed a Biologics License Application with the US Food and Drug Administration for accelerated approval for their 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 top-line 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.
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