Genmab A/S announced that the European Commission (EC) has granted marketing authorization for TIVDAK (tisotumab vedotin) as monotherapy for adult patients with recurrent or metastatic cervical cancer. This approval is for patients whose disease has progressed on or after systemic therapy, making TIVDAK the first and only antibody-drug conjugate (ADC) approved for this indication in the European Union.
The EC approval is supported by data from the global, randomized, Phase 3 innovaTV 301 trial, which demonstrated a 30% reduction in the risk of death (HR: 0.70) compared to chemotherapy. Median overall survival (OS) was 11.5 months for TIVDAK-treated patients versus 9.5 months for those receiving chemotherapy.
TIVDAK also met secondary endpoints, showing a 33% reduction in the risk of disease progression (HR: 0.67) and a confirmed objective response rate. This approval addresses a high unmet need in Europe, where cervical cancer is the 11th most frequently occurring cancer among women, with limited treatment options for advanced forms of the disease.
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