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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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