FDA Approves Tisotumab Vedotin for Patients With Recurrent or Metastatic Cervical Cancer

On April 29, 2024, the US Food and Drug Administration (FDA) approved tisotumab vedotin for patients with recurrent or metastatic cervical cancer who experienced disease progression on or after systemic treatment. This approval was based on results from the phase 3 innovaTV 301 trial. 

This open-label, active-controlled trial enrolled 502 patients with recurrent or metastatic cervical cancer who received 1 to 2 prior lines of systemic therapy, including chemotherapy with or without bevacizumab and/or an anti PD-L1 agent. Patients were randomized on a 1-to-1 basis to receive either 2 mg/kg of intravenous tisotumab vedotin or investigator’s choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) every 3 weeks until disease progression or unacceptable toxicity. The major efficacy outcome was overall survival (OS). Secondary efficacy outcomes included investigator-assessed progression-free survival (PFS) and confirmed objective response rate (ORR). 

At analysis, median OS was 11.5 months in the tisotumab vedotin arm and 9.5 months in the chemotherapy arm (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.54 to 0.89; P = .0038). Median PFS was 4.2 months in the tisotumab vedotin arm and 2.9 months in the chemotherapy arm (HR, 0.67; 95% CI, 0.54 to 0.82; P < .0001). Confirmed ORR was 17.8% in the tisotumab vedotin arm and 5.2% in the chemotherapy arm (P < .0001). The most common adverse reactions occurring in ≥25% of patients, including laboratory abnormalities, included decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, fatigue, decreased sodium, epistaxis, and constipation. 

The recommended dose of intravenous tisotumab vedotin is 2 mg/kg (200 mg maximum for patients ≥100 kg) administered for 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

This approval amends the previous accelerated approval of tisotumab vedotin.

Source:

FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer. Published online: April 29, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer