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Genmab, Seagen File US Application For Tisotumab Vedotin In Cervical Cancer Setting

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  • Genmab (NASDAQ: GMAB) and Seagen Inc (NASDAQ: SGEN) have jointly announced the submission of a marketing application with the 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.

  • The submission is based on the innovaTV 204 pivotal Phase 2 single-arm trial results evaluating tisotumab vedotin as monotherapy in this setting. Topline results from the phase 2 study were announced in June 2020, and data were presented at the European Society for Medical Oncology Virtual Congress 2020.

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

  • Price Action: SGEN closed 3.6% lower at $169.35, and GMAB was down 1.5% at $40.37 on Wednesday.

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