Genmab has received approval from the Japan’s Ministry of Health, Labour and Welfare for Tivdak (tisotumab vedotin) to treat advanced or recurrent cervical cancer that progressed on or following chemotherapy.
This is the first approval of an antibody-drug conjugate (ADC) for cervical cancer patients in the country.
Go deeper with GlobalData
The approval is grounded on the open-label Phase III innovaTV 301 clinical trial data that assessed the safety and efficacy of the therapy against chemotherapy.
The trial comprised 502 participants, 101 of whom were Japanese.
It met the overall survival (OS) goal, which was its primary endpoint, showing a 30% decrease in the mortality risk against chemotherapy.
Genmab chief development officer and executive vice-president Judith Klimovsky stated: “As a company, we understand the urgent need of patients with advanced cervical cancer whose disease has progressed.
“This approval marks an important step forward in transforming the treatment paradigm in Japan, ultimately bringing new hope and possibility to patients and their loved ones.”
The trial was conducted by Seagen in partnership with Genmab, the Gynecologic Oncology Group (GOG) Foundation and the European Network of Gynaecological Oncological Trial Groups, along with other international gynaecological oncology co-operative groups.
Pfizer acquired Seagen in December 2023.
Tivdak comprises Genmab’s human monoclonal antibody directed to tissue factor (TF) with the ADC technology of Pfizer, which leverages a protease-cleavable linker covalently attaching the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody.
Genmab and Pfizer jointly developed and commercialised the antibody worldwide, sharing profits and expenses under their agreement.
In Japan and global regions other than China and the US, Genmab spearheads commercialisation for previously treated recurrent or metastatic cervical cancer.
