The European Medicines Agency (EMA) has validated a marketing authorisation application (MAA) from Genmab AS and Pfizer Inc. to review tisotumab vedotin, an antibody-drug conjugate (ADC) developed to treat adult patients with recurring or metastatic cervical cancer. If approved, tisotumab vedotin would be the first ADC authorised for marketing in the European Union (EU) for patients living with cervical cancer.
This MAA is rooted in data from the global randomized Phase 3 innovaTV 301 trial. Here, tisotumab vedotin displayed 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 sourced from the innovaTV 204 pivotal Phase 2 single-arm clinical trial evaluating TIVDAK, in patients with previously treated recurrent or metastatic cervical cancer, was also included in the MAA. The drug’s safety profile, as depicted in innovaTV 301, remained aligned with its known U.S. prescribing information.
Cervical cancer is the fourth leading cause of cancer death in women globally. Despite advances in vaccination and screening methodologies to prevent and identify pre- and early-stage cancers for curative treatment, it still presents a high unmet medical requirement. Annually, almost 570,000 fresh cases are recognised, and 311,000 women lose their lives to this disease. A particularly crushing type of this disease is recurrent and/or metastatic cervical cancer, which, if diagnosed during the later stages, proves mostly incurable, with less than 5% of afflicted patients surviving five years.
Genmab and Pfizer’s partnership aims to bridge this healthcare gap, with the latter’s Chief Development Officer, Oncology, Roger Dansey, affirming that they are during the process of potentially offering a new therapeutic option for patients battling this debilitating disease.
Genmab’s CEO, Jan van de Winkel, shared a similar sentiment, saying, “Validation of our application denotes a significant stride in our commitment to bring a new therapeutic alternative for recurring or metastatic cervical cancer to patients worldwide.”
