Genmab A/S announced that the Japan Ministry of Health, Labour and Welfare has approved TIVDAK (tisotumab vedotin) for the treatment of advanced or recurrent cervical cancer that has progressed on or after cancer chemotherapy. TIVDAK is the first and only antibody-drug conjugate (ADC) to receive approval for cervical cancer in Japan.
The approval is based on data from the global, randomized, open-label Phase 3 innovaTV 301 clinical trial. This trial demonstrated a 30% reduction in the risk of death (HR: 0.70) compared to chemotherapy, with a median overall survival (OS) of 11.5 months for TIVDAK-treated patients versus 9.5 months for chemotherapy.
Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) were also met, further supporting its clinical benefit. This approval addresses a significant unmet medical need in Japan, where cervical cancer incidence and mortality rates have been increasing, particularly among women under 50.
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