FDA grants full approval for Tivdak (tisotumab vedotin-tftv) to treat recurrent or metastatic cervical cancer
Pfizer Inc.and Genmab A/S announced the FDA approves the supplemental Biologics License Application (sBLA) granting full approval for Tivdak (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
"Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, Executive Vice President at Pfizer. “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 approval is based on results from the global, randomized, Phase III innovaTV 301 clinical trial (NCT04697628), which met its primary endpoint, demonstrating overall survival (OS) benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with Tivdak compared to chemotherapy. Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) were also met. In October 2023, results from the innovaTV 301 study were presented during the Presidential session at the European Society of Medical Oncology (ESMO) Congress.
The innovaTV 301 study demonstrated a 30% reduction in the risk of death compared to chemotherapy (hazard ratio [HR]: 0.70 [95% CI: 0.54-0.89], two-sided p=0.0038). Median OS for patients treated with TIVDAK was 11.5 months [95% CI: 9.8-14.9] versus chemotherapy 9.5 months [95% CI: 7.9-10.7].
150 mins
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.