TIVDAK (Tisotumab vedotin) approved by Japan Ministry of Health, Labour and Welfare for the treatment of advanced or recurrent Cervical cancer that has progressed on or after chemotherapy

CAR-T Digest - August 2020

Weekly Digest - March 2025

27 Mar 2025: TIVDAK (Tisotumab vedotin) approved by Japan Ministry of Health, Labour and Welfare for the treatment of advanced or recurrent Cervical cancer that has progressed on or after chemotherapy

TIVDAK (Tisotumab vedotin) is the first and only ADC approved for advanced or recurrent cervical cancer in Japan, offering a new treatment option for patients with limited choices
Approval is based on the results from the global Phase 3 innovaTV 301 trial, where TIVDAK demonstrated a 30% reduction in the risk of death compared to chemotherapy, improving overall survival in patients with advanced cervical cancer
Cervical cancer incidence and mortality rates have been rising in Japan, especially among women under 50, highlighting the urgent need for innovative treatment options like TIVDAK
The Phase 3 trial included 502 patients and showed significant improvements in OS, PFS, and response rates, despite common adverse reactions such as conjunctivitis and nausea
Tisotumab vedotin works by targeting tissue factor-expressing cancer cells, using a microtubule-disrupting agent to trigger cell death, and is co-developed and commercialized by Genmab and Pfizer