Genmab (GMAB) said Thursday that Japan's Ministry of Health, Labour and Welfare has approved Tivdak, or tisotumab vedotin, for advanced or recurrent cervical cancer that has progressed on or after chemotherapy.
The company said the approval was based on data from a late-stage trial involving 502 patients, which met its primary and secondary endpoints.
Genmab said the trial showed that Tivdak reduced the risk of death by 30% when compared to chemotherapy, with a median overall survival of 11.5 months for Tivdak and 9.5 for chemotherapy.
Shares of the company were up more than 1% in recent Thursday premarket activity.
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