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A New Hope for Cervical Cancer Patients: EU Approves TIVDAK

EU grants approval for TIVDAK, the first ADC for advanced cervical cancer, offering new hope to patients.

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  • Apr 01, 2025

  • Mrudula Kulkarni

A New Hope for Cervical Cancer Patients: EU Approves TIVDAK

In a significant step forward for cervical cancer treatment, the European Commission (EC) has approved TIVDAK (tisotumab vedotin), the first antibody-drug conjugate (ADC) authorized in the EU for recurrent or metastatic cervical cancer. Developed by Genmab A/S, this approval provides a much-needed alternative for patients whose disease has progressed despite prior therapies. The decision is backed by strong Phase 3 trial data, showing that TIVDAK reduces the risk of death by 30% compared to chemotherapy, with a manageable safety profile. Given the high recurrence rates and limited treatment options for advanced cervical cancer, this milestone offers new hope for patients navigating a difficult journey.

“TIVDAK represents more than just a new treatment—it’s a potential lifeline for patients facing a devastating prognosis,” said Brad Bailey, Chief Commercial Officer at Genmab. With data from the innovaTV 301 trial confirming its superior efficacy, the approval underscores a shift in the treatment landscape. Patients in Europe will now have access to a therapy that not only extends survival but also offers an innovative mechanism of action against the disease. As Genmab prepares for the rollout, the focus remains on ensuring broad patient access to this promising new therapy.

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