The National Institute for Health and Care Excellence (NICE) has recommended Genmab UK’s Tivdak (tisotumab vedotin) for adults with recurrent or metastatic cervical cancer.
Tivdak is an antibody-drug conjugate (ADC) that can be used to treat adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
Cervical cancer is the fourth leading cause of cancer-related deaths globally among women. It is estimated that 3,300 women are diagnosed with cervical cancer each year in the UK, resulting in approximately 900 deaths. The disease recurs in up to 30% of cases among patients who have improved with initial treatment.
“Despite real progress in prevention and early detection, women with metastatic or recurrent cervical cancer still face poor outcomes and limited options beyond chemotherapy. While early-stage care has improved, there remains an urgent need for women whose cancer returns or spreads, said Professor Susana Banerjee, UK lead for the phase 3 innovaTV 301 trial, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, London and Professor in Women’s Cancers at the Institute of Cancer Research.
The recommendation is based on results from the global, randomised, phase 3 innovaTV 301 study that evaluated the efficacy and safety of tisotumab vedotin compared to chemotherapy in patients with recurrent or metastatic cervical cancer who were previously treated with chemotherapy doublet as well as bevacizumab and an anti–PD-1 or anti–PD-L1 agent if eligible and available.
Lisa Barraclough, consultant clinical oncologist’, said: ‘There remains a significant unmet need for women with cervical cancer whose disease returns or progresses after initial treatment. This marks very important progress for women living with this disease and enables us to offer an alternative treatment in a setting where choices have long been limited.”
Matt Kiely, General Manager, UK at Genmab, said: “The positive NICE recommendation for tisotumab vedotin marks an important milestone for eligible women living with recurrent or metastatic cervical cancer.
“As the first antibody-drug conjugate licensed in this setting, tisotumab vedotin broadens the options available to clinicians and reflects our commitment to improving outcomes for women affected by gynaecological cancers.”
Interim funding via the Cancer Drugs Fund (CDF) will give eligible patients immediate access to the treatment. Subject to final NICE guidance, the treatment is expected to be routinely funded and available for use on the NHS shortly thereafter.