Genmab (GMAB) said Monday that the European Commission has granted marketing authorization for Tivdak as a treatment for adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
The company said the approval was based on data from a phase 3 trial that met its primary endpoint of overall survival, with Tivdak demonstrating a 30% reduction in risk of death compared with chemotherapy.
Tivdak, also known as tisotumab vedotin, is co-developed and co-commercialized by Genmab and Pfizer (PFE) globally, with Pfizer holding its marketing authorization in the European Union until its transfer to Genmab within the year, according to the statement.
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