The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) for review of Genmab and Pfizer’s tisotumab vedotin to treat recurrent or metastatic cervical cancer.
The antibody-drug conjugate (ADC) would become the first treatment option in the European Union for adult cervical cancer patients whose disease has advanced on or following systemic therapy.
The MAA submission is based on results from the randomised, international Phase III innovaTV 301 trial.
The trial enrolled 502 patients who had received no more than two systemic regimens previously for recurrent or metastatic cervical cancer.
Tisotumab vedotin demonstrated improved overall survival, progression-free survival and objective response rates.
The findings are compared to those obtained from chemotherapy treatments.
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The primary goal of the study was to assess overall survival, while secondary outcomes included progression-free survival and quality-of-life measures.
Data from the innovaTV 204 Phase II single-arm trial of tisotumab vedotin monotherapy was also included in the application.
The safety profile observed in the innovaTV 301 trial aligns with the known safety information provided in the US prescribing details.
Genmab CEO Jan van de Winkel stated: “The validation of our application is an important milestone supporting our commitment to bringing a new therapeutic option for recurring or metastatic cervical cancer to more patients.
“There continues to be a need for therapeutic options for these patients, and we’re dedicated to delivering potentially improved outcomes to women diagnosed with this devastating disease.”
Tisotumab vedotin combines Genmab’s human monoclonal antibody targeting tissue factor with the ADC technology of Pfizer.
Pfizer Oncology chief development officer Roger Dansey stated: “The milestone signifies our progress in exploring the availability of tisotumab vedotin for more patients with recurrent or metastatic cervical cancer.
“We remain dedicated to collaborating closely with regulatory authorities, while we navigate the process to potentially deliver a new therapeutic option to people facing this debilitating disease.”
