TIVDAK (Tisotumab vedotin) approved by European Commission for previously treated recurrent or metastatic Cervical cancer

CAR-T Digest - August 2020

31 Mar 2025: TIVDAK (Tisotumab vedotin) approved by European Commission for previously treated recurrent or metastatic Cervical cancer

The European Commission has approved TIVDAK (Tisotumab vedotin) as the first and only ADC for treating recurrent or metastatic Cervical cancer in adults who have experienced disease progression after systemic therapy
This approval is based on the global Phase 3 innovaTV 301 trial, which showed TIVDAK significantly improved overall survival compared to chemotherapy, reducing the risk of death by 30% (median OS: 11.5 vs. 9.5 months)
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
TIVDAK is already approved in the EU, US, and Japan, and its approval marks Genmab’s first independent product launch in Europe