Tisotumab vedotin marketing authorization application validated by EMA for treatment of recurrent metastatic cervical cancer.- Genmab A/S + Pfizer, Inc.
Genmab A/S and Pfizer, Inc. announced that the European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) of tisotumab vedotin, an antibody-drug conjugate (ADC), developed for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
If approved, tisotumab vedotin would be the first ADC granted European Union (EU) marketing authorization for people living with cervical cancer.
The MAA is based on data from the global, randomized, Phase III innovaTV 301 trial (NCT04697628), in which tisotumab vedotin demonstrated superior overall survival (OS), progression-free survival (PFS) and a confirmed objective response rate (ORR) in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy. Data from the innovaTV 204 pivotal Phase II single-arm clinical trial evaluating Tivdak as monotherapy in patients with previously treated recurrent or metastatic cervical cancer was also included in the MAA. The safety profile of tisotumab vedotin in innovaTV 301 was consistent with its known safety profile as presented in the U.S. prescribing information.
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