Oncology Drug Approval News Flash: Tisotumab vedotin-tftv (Tivdak) Approved by FDA for Recurrent or Metastatic Cervical Cancer

[FDA Approval Alert] Tisotumab vedotin-tftv by Seagen and Genmab approved for recurrent/metastatic cervical cancer (June 21, 2025)

On June 21, 2025, the U.S. FDA approved Tisotumab vedotin-tftv (Tivdak) for the treatment of recurrent or metastatic cervical cancer in patients whose disease progressed after chemotherapy. The approval was based on results from the phase III innovaTV 301 trial and represents an important step in expanding antibody-drug conjugate (ADC) therapies.

Disease Overview: Cervical Cancer

Cervical cancer is primarily caused by persistent infection with human papillomavirus (HPV). In advanced stages, treatment options include chemotherapy, radiation, and increasingly, targeted and immunotherapies.

Therapy Summary

• Drug: Tisotumab vedotin-tftv (Tivdak)
• Companies: Seagen / Genmab
• Approval Date: June 21, 2025
• Indication: Recurrent or metastatic cervical cancer (post-chemotherapy)
• Mechanism: ADC targeting tissue factor (TF)
• Key Study: innovaTV 301 (Phase III)
• Key Result: Overall survival improvement (HR 0.70, p=0.0031)

Patient Explanation

This ADC offers a promising new option for patients with recurrent or metastatic cervical cancer by extending survival compared to standard treatment options.

M&A and Investment Info

• Subsidiary Info: Seagen is now a Pfizer company
• Acquisition Date: December 2023
• Development Status at Acquisition: In phase III trial
• Investor Info: Pfizer (NYSE: PFE), Genmab (NASDAQ: GMAB)

Source

This approval information is based on Drugs@FDA from the U.S. Food and Drug Administration.