Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE: PFE) have reported that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for tisotumab vedotin. This antibody-drug conjugate (ADC) is developed for treating adult patients with recurrent or metastatic cervical cancer, showing disease progression after systemic therapy.

The MAA is founded on data from the global Phase 3 innovaTV 301 trial (NCT04697628), where tisotumab vedotin displayed superior overall survival, progression-free survival, and a confirmed objective response rate compared to chemotherapy. Data from the innovaTV 204 Phase 2 trial evaluating TIVDAK as monotherapy was also included in the MAA. The safety profile of tisotumab vedotin in innovaTV 301 was consistent with the known safety profile in the U.S. prescribing information.

Genmab's CEO, Jan van de Winkel, emphasized the significance of the application's validation, underscoring the commitment to providing a new therapeutic option for patients with recurrent or metastatic cervical cancer.

Pfizer's Chief Development Officer, Oncology, Roger Dansey, highlighted the progress made in exploring tisotumab vedotin's availability for more patients, expressing dedication to collaboration with regulatory authorities for potential delivery of a new therapeutic option in the fight against cervical cancer.