Tivdak Gets Traditional Approval for Recurrent or Metastatic Cervical Cancer

The Food and Drug Administration (FDA) has granted full approval to Tivdak^® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The conversion from accelerated to traditional approval was based on data from the phase 3 innovaTV 301 clinical trial (ClinicalTrials.gov Identifier: NCT04697628), which evaluated tisotumab vedotin vs investigator’s choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) in 502 patients with recurrent or metastatic cervical cancer who received no more than 2 prior systemic regimens in the recurrent or metastatic setting. 

The primary outcome of the study was overall survival (OS). Progression free survival (PFS) and objective response rate (ORR) were assessed as secondary outcomes.

Results showed treatment with tisotumab vedotin statistically significantly improved OS compared with chemotherapy (hazard ratio [HR], 0.70 [95% CI, 0.54-0.89]; P =.0038). Median OS was 11.5 months (95% CI, 9.8-14.9) with tisotumab vedotin and 9.5 months (95% CI, 7.9-10.7) with chemotherapy. Improvements in PFS (HR, 0.67 [95% CI, 0.54-0.82]; P <.0001) and ORR (17.8% vs 5.2%; P <.0001) were also observed for tisotumab vedotin vs chemotherapy. 

The most common adverse reactions reported with tisotumab vedotin were decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, fatigue, decreased sodium, epistaxis, and constipation.

“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,” said Jan van de Winkel, PhD, Chief Executive Officer of Genmab. “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.”

According to the FDA, results from innovaTV 301 fulfill the postmarketing requirement of the previous accelerated approval.