FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer

FDA regulatory approval (April 29, 2024)

The FDA granted traditional approval to tisotumab vedotin-tftv (Tivdak; Seagen, now part of Pfizer) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The product previously received accelerated approval for this indication.

Supporting evidence: innovaTV 301 (NCT04697628)

Approval was supported by innovaTV 301, an open-label, active-controlled, multicenter, randomized (1:1) trial enrolling 502 patients with recurrent/metastatic cervical cancer who had received 1–2 prior systemic regimens, including chemotherapy with or without bevacizumab and/or an anti–PD-(L)-1 agent.

Patients received tisotumab vedotin 2 mg/kg IV every 3 weeks or investigator’s choice chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) until progression or unacceptable toxicity.

Efficacy

• Overall survival (primary endpoint): median 11.5 vs 9.5 months (HR 0.70, 95% CI 0.54–0.89; p=0.0038)
• PFS: median 4.2 vs 2.9 months (HR 0.67; p<0.0001)
• Confirmed ORR: 17.8% vs 5.2% (p<0.0001)

The results fulfilled the post-marketing requirement from the prior accelerated approval.

Safety (common adverse reactions ≥25%)

Decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased AST/ALT, nausea, fatigue, decreased sodium, epistaxis, and constipation.

Recommended dose (per FDA)

2 mg/kg (maximum 200 mg for patients ≥100 kg) IV over 30 minutes every 3 weeks until progression or unacceptable toxicity.