Drug Innovation - Tisotumab vedotin-tftv, marketed as Tivdak

Product Approval for Cervical Cancer Drug  

Exciting news emerged from the U.S. Food and Drug Administration (FDA) on April 29, 2024, as traditional approval was granted to tisotumab vedotin-tftv, marketed as Tivdak by Seagen Inc. (now a part of Pfizer Inc.). This milestone marks a significant advancement in the treatment landscape for recurrent or metastatic cervical cancer patients who have experienced disease progression following chemotherapy. 

Efficacy and Safety 

The approval was based on findings from the innovaTV 301 trial, which enrolled 502 patients with recurrent or metastatic cervical cancer who had undergone one or two prior systemic regimens, including chemotherapy.  

Patients were randomized to receive either tisotumab vedotin-tftv or investigator’s choice of chemotherapy until unacceptable toxicity or disease progression. 

The study demonstrated promising efficacy outcomes, with tisotumab vedotin-tftv showing significant improvements in overall survival (OS), progression-free survival (PFS), and confirmed objective response rate (ORR) compared to chemotherapy. Median OS was 11.5 months in the tisotumab vedotin-tftv arm versus 9.5 months in the chemotherapy arm.  

Additionally, the most common adverse reactions observed included decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, and others. 

Recommended Dosage 

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

Expedited Programs 

The application was facilitated by FDA’s expedited review process using Assessment Aid, including priority review designation. Expedited programs aim to accelerate the development and approval of therapies for serious conditions, such as cervical cancer. 

FDA Assistance 

Healthcare professionals seeking assistance with single-patient INDs for investigational oncology products may contact OCE’s Project Facilitate (https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate) at 240-402-0004 or email. 

Conclusion 

The traditional approval of tisotumab vedotin-tftv represents a significant advancement in the management of recurrent or metastatic cervical cancer.  

Healthcare professionals are encouraged to stay informed about this treatment option and report any adverse events associated with its use to the FDA’s MedWatch Reporting System. 

Links 

View the FDA new product announcement. 

Stay updated on the latest developments in oncology by following the Oncology Center of Excellence on X (formerly Twitter) @FDAOncology.