The full approval is based on positive results from global Phase 3 innovaTV 301 study that showed overall survival benefit of Tivdak in comparison to chemotherapy
FDA grants full approval to Pfizer and Genmab’s Tivdak for recurrent or metastatic cervical cancer. (Credit: Pfizer Inc.)
The US Food and Drug Administration (FDA) has granted full approval to Pfizer and Genmab’s Tivdak (tisotumab vedotin-tftv) to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy.
Tivdak is an antibody-drug conjugate (ADC) treatment made from Genmab’s human monoclonal antibody targeting tissue factor and Pfizer’s ADC technology.
In September 2021, Tivdak secured the FDA’s accelerated approval for the same indication based on the data from the innovaTV 204 Phase 2 single-arm trial.
Pfizer chief oncology officer and executive vice president Chris Boshoff said: “Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options.
“Today’s full approval by the FDA reinforces the important role of TIVDAK for these patients, as the first antibody-drug conjugate with statistically significant prolonged overall survival data.”
The conversion to full approval was driven based on findings from the global, randomised, Phase 3 innovaTV 301 clinical study.
The trial assessed Tivdak against investigator’s choice of single-agent chemotherapy in 502 patients with recurrent or metastatic cervical cancer.
The innovaTV 301 study achieved its primary endpoint, showing an increase in overall survival (OS).
The study showed a 30% reduction in the risk of death compared to chemotherapy. The median OS for patients treated with Tivdak was observed at 11.5 months compared to chemotherapy at 9.5 months.
Additionally, secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) were also met by the innovaTV 301 trial.
The safety profile of the ADC treatment in the late-stage trial was found to be on par with its known safety profile as per its US prescription, with no new issues identified.
Genmab CEO Jan van de Winkel said: “The full FDA approval of Tivdak represents a significant achievement for women with recurrent and metastatic cervical cancer, reinforcing Tivdak as a treatment option that has proven to extend survival in patients whose disease has advanced after initial treatments.
“This milestone underscores the importance of our ongoing clinical development program to assess the full potential of tisotumab vedotin as a treatment option in other indications.”