Japanese Drug Regulator Approves Genmab Cancer Drug For Patients With Advanced Cervical Cancer

The Japanese Ministry of Health, Labour and Welfare on Thursday approved Genmab A/S’ Tivdak (tisotumab vedotin) for advanced or recurrent cervical cancer that has progressed on or after cancer chemotherapy.

Tivdak is the first and only antibody-drug conjugate (ADC) to be approved for cervical cancer in Japan.

The approval is based on data from the Phase 3 innovaTV 301 clinical trial that evaluated the efficacy and safety of TIVDAK compared to chemotherapy in patients with advanced or recurrent cervical cancer who were previously treated with chemotherapy.

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The trial included 502 patients, 101 of which were Japanese.

The trial met its primary endpoint of overall survival (OS), demonstrating a 30% reduction in risk of death compared to chemotherapy.

Median OS was 11.5 months among patients treated with Tivdak compared to 9.5 months for patients who received chemotherapy. Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) were also met.

Tisotumab vedotin is co-developed and co-commercialized globally by Genmab ( GMAB ) and Pfizer Inc ( PFE ) under an agreement in which the companies share costs and profits.

With respect to the commercialization of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer, Genmab ( GMAB ) leads commercialization in Japan and all other regions globally, outside the United States and China. In these regions, Pfizer ( PFE ) partners with Genmab ( GMAB ) and Zai Lab, respectively, on commercialization.

Price Action: GMAB stock is up 3.06% at $20.22 at the last check Thursday.

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