The Japanese Ministry of Well being, Labour and Welfare on Thursday accepted Genmab A/S’ GMAB Tivdak (tisotumab vedotin) for superior or recurrent cervical most cancers that has progressed on or after most cancers chemotherapy.
Tivdak is the primary and solely antibody-drug conjugate (ADC) to be accepted for cervical most cancers in Japan.
The approval relies on knowledge from the Section 3 innovaTV 301 scientific trial that evaluated the efficacy and security of TIVDAK in comparison with chemotherapy in sufferers with superior or recurrent cervical most cancers who had been beforehand handled with chemotherapy.
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The trial included 502 sufferers, 101 of which had been Japanese.
The trial met its main endpoint of general survival (OS), demonstrating a 30% discount in danger of loss of life in comparison with chemotherapy.
Median OS was 11.5 months amongst sufferers handled with Tivdak in comparison with 9.5 months for sufferers who acquired chemotherapy. Secondary endpoints of progression-free survival (PFS) and confirmed goal response charge (ORR) had been additionally met.
Tisotumab vedotin is co-developed and co-commercialized globally by Genmab and Pfizer Inc PFE underneath an settlement by which the businesses share prices and earnings.
With respect to the commercialization of tisotumab vedotin in beforehand handled recurrent or metastatic cervical most cancers, Genmab leads commercialization in Japan and all different areas globally, outdoors the USA and China. In these areas, Pfizer companions with Genmab and Zai Lab, respectively, on commercialization.
Value Motion: GMAB inventory is up 3.06% at $20.22 on the final verify Thursday.
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Momentum18.16
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