Genmab and Pfizer announced that the European Medicines Agency (EMA) has validated for review their joint marketing authorisation application (MAA) for tisotumab vedotin.

Tisotumab vedotin is an antibody-drug conjugate (ADC) intended for the treatment of adult patients with metastatic cervical cancer with disease progression on or after systemic therapy.

The drug combines the Dutch biotech company’s human monoclonal antibody directed to tissue factor (TF) and the US drugmaker’s ADC technology that leverages a protease-cleavable linker.

The protease-cleavable linker covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody, which leads to cell cycle arrest and apoptotic cell death.

Tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

If approved, tisotumab vedotin would be the first ADC to receive European Union (EU) marketing authorisation for people living with cervical cancer.

Pfizer oncology chief development officer Roger Dansey said: “Today’s 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.”

Genmab and Pfizer’s MAA is based on data from the innovaTV 301, a global, randomised, Phase 3 clinical study in 502 patients with recurrent or metastatic cervical cancer.

In the study, tisotumab vedotin showed positive results including superior overall survival (OS), progression-free survival (PFS) and a confirmed objective response rate (ORR).

The study was conducted by Seagen, which was recently acquired by Pfizer, in collaboration with Genmab, the European Network of Gynaecological Oncological Trial Groups (ENGOT) and the Gynecologic Oncology Group (GOG) foundation.

Tisotumab vedotin showed a safety profile that was consistent with its known safety profile as presented in the US prescribing information.

The MAA also includes data from the Phase 2 innovaTV 204 study of TIVDAK as monotherapy in patients with previously treated metastatic cervical cancer.

Tisotumab vedotin-tftv (Tivdak) is already approved by the US Food and Drug Administration (FDA), under its accelerated approval programme.

The US health agency also granted Priority Review for a supplemental Biologics License Application (sBLA) to convert its accelerated approval to full approval.

Genmab CEO Jan van de Winkel said: “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 potential improved outcomes to women diagnosed with this devastating disease.”