2 February 2024 - Genmab and Pfizer today announced that the EMA has validated for review the marketing authorisation application of tisotumab vedotin, an antibody-drug conjugate, developed for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
The marketing authorisation application is based on data from the global, randomized, Phase 3 innovaTV 301 trial, in which tisotumab vedotin demonstrated superior overall survival, progression-free survival and a confirmed objective response rate in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.