Pfizer and Genmab have announced that the US Food and Drug Administration (FDA) has granted full approval for Tivdak (tisotumab vedotin-tftv) to treat recurrent or metastatic cervical cancer.
The FDA’s decision specifically applies to patients with disease progression on or after chemotherapy and builds on the accelerated approval it gave to the antibody-drug conjugate (ADC) in 2021.
It was estimated that more than 13,960 new cases of invasive cervical cancer, a disease with high unmet need despite advances in effective vaccination and screening practices, were diagnosed in the US last year.
Up to 15% of adults with cervical cancer present with metastatic disease at diagnosis and for those diagnosed at earlier stages who receive treatment, up to 61% will experience disease recurrence.
The latest approval for Tivdak, which is composed of Genmab’s human monoclonal antibody directed to tissue factor and Pfizer’s ADC technology, was supported by positive results from the late-stage innovaTV 301 trial.
The study met its primary endpoint, demonstrating an overall survival benefit in adults with previously treated recurrent or metastatic cervical cancer treated with Tivdak compared to chemotherapy.
Secondary endpoints of progression-free survival and confirmed objective response rate were also met, and the safety profile of the drug was consistent with its known safety profile.
Chris Boshoff, chief oncology officer, executive vice president at Pfizer, said: “Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options.
“[The] full approval by the FDA reinforces the important role of Tivdak for these patients as the first ADC with statistically significant prolonged overall survival data.”
Jan van de Winkel, chief executive officer of Genmab, said: “The full FDA approval of Tivdak represents a significant achievement for women with recurrent and metastatic cervical cancer… This milestone underscores the importance of our ongoing clinical development programme to assess the full potential of [Tivdak] as a treatment option in other indications.”
Pfizer gained access to Tivdak through its $43bn acquisition of Seagen, which was completed in December 2023.
The merger marked a significant boost to Pfizer’s oncology pipeline and granted it access to Seagen’s proprietary ADC technology.