Genmab has announced that the European Commission (EC) has approved Tivdak (tisotumab vedotin) to treat recurrent or metastatic cervical cancer.
The drug has been specifically authorised to treat adults experiencing disease progression on or after systemic therapy, and is now the first antibody-drug conjugate (ADC) to be approved in the EU for recurrent or metastatic cervical cancer.
Despite progress in cervical cancer prevention and early detection, the disease is the fourth most common cancer in women globally, with approximately 660,000 cases diagnosed in 2022 alone.
Up to 15% of adults present with metastatic disease at diagnosis, and as many as 61% of those diagnosed at earlier stages will experience disease recurrence after treatment.
Tivdak is composed of Genmab’s human monoclonal antibody directed to tissue factor and Pfizer’s ADC technology. Genmab leads commercialisation of the drug in Europe and all other regions outside the US and China, where Pfizer partners with Genmab and Zai Lab, respectively.
The EC’s decision was supported by positive results from the late-stage innovaTV 301 trial, in which Tivdak demonstrated a 30% reduction in risk of death compared to chemotherapy. Median overall was 11.5 months among Tivdak-treated patients and 9.5 months for those randomised to receive chemotherapy.
Secondary endpoints of progression-free survival and confirmed objective response rate were also met, with Tivdak reducing the risk of disease progression by 33% compared to chemotherapy.
Lead investigator on the innovaTV 301 clinical trial, Ignace Vergote, described the EC approval as “an important step forward in the treatment landscape for advanced cervical cancer”.
Vergote said: “Recurrent or metastatic cervical cancer is a devastating disease, and patients can face a difficult treatment journey with limited options.
“In clinical trials, Tivdak demonstrated a superior overall survival benefit and manageable safety profile compared to chemotherapy, supporting its position to become a potential new standard of care in this setting with a novel mechanism of action.”
The approval comes just under a year after the FDA granted full approval for Tivdak in recurrent or metastatic cervical cancer, building on the accelerated approval it gave to the drug in 2021.