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(1) - FDA Action Date is October 10, 2021 - - BLA Submission Supported by Positive Pivotal innovaTV 204 Trial Results Presented at the European Society of Medical Oncology Virtual Congress 2020 - Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (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. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of October 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 prog

United statesNew jerseyRoger danseyMarisol peronPeggy pinkstonTisotumab vedotinSemin thromb hemostAndrew carlsenNational cancer instituteEuropean network of gynaecological oncological trial groupsEuropean society of medical oncology virtual congressDrug administrationGynecologic oncology groupSeagen incExchange commissionCompany annual report on form