NICE Recommends TIVDAK®▼ (tisotumab vedotin) for the Treatment of Eligible Recurrent or Metastatic Cervical Cancer Patients with Disease Progression On or After Systemic Therapy
London, United Kingdom – 22 May 2026
Genmab UK Ltd. (Nasdaq: GMAB) announced today that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending the use of TIVDAK ® (tisotumab vedotin), an antibody-drug conjugate (ADC), within its marketing authorisation for the monotherapy treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. 1 From today, interim funding via the Cancer Drugs Fund (CDF) will enable immediate access to tisotumab vedotin for eligible patients. Subject to final NICE guidance, tisotumab vedotin is expected to be routinely funded and available for use on the National Health Service (NHS) shortly thereafter.
Globally, cervical cancer is the fourth leading cause of cancer-related death among women 4. In the U.K. every year, it is estimated that 3,300 women are diagnosed with cervical cancer 2 and approximately 900 women die from the disease. 5 Among those who respond to initial treatment, recurrence occurs in up to 30% of cases. 3
“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. As a first-in-class antibody-drug conjugate recommended by NICE for this patient population, tisotumab vedotin broadens the range of treatment options available and may offer clinically meaningful improvement in survival outcomes for some patients in this hard-to-treat setting,” said Professor Susana Banerjee, U.K. 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 6 that evaluated the efficacy and safety of tisotumab vedotin (n=253) compared to chemotherapy (n=249) 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.
''There remains a significant unmet need for women with cervical cancer whose disease returns or progresses after initial treatment. NICE’s recommendation of tisotumab vedotin for eligible patients with recurrent or metastatic disease for use in the NHS is an extremely welcome step forward,” said Dr Lisa Barraclough, Consultant Clinical Oncologist. “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.”
“Today’s positive NICE recommendation for tisotumab vedotin marks an important milestone for eligible women living with recurrent or metastatic cervical cancer,” said Matt Kiely, General Manager, U.K., Genmab. “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. We look forward to working with the NHS, clinicians and patient groups to support timely access and smooth implementation.”
Notes to editors
About the innovaTV 301 Trial
The innovaTV 301 trial (CTIS 2023-503813-31-01 / NCT04697628) is a global, 1:1 randomised, open-label Phase 3 trial evaluating tisotumab vedotin versus investigator’s choice of single agent chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed) in 502 patients with recurrent or metastatic cervical cancer who received one or two prior systemic regimens in the recurrent or metastatic setting.
Select inclusion criteria for the study included patients with recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma or adenosquamous histology, and disease progression during or after treatment with chemotherapy doublet +/- bevacizumab and an anti-PD-(L)1 agent (if eligible).
The primary endpoint of the study was overall survival (OS). In the study, after a median follow up of 10.8 months (95% confidence interval [CI]: 10.3-11.6), and with 263 deaths having occurred, the median OS was 11.5 months in the tisotumab vedotin group (95% CI: 9.8-14.9) and 9.5 months in the chemotherapy group (95% CI: 7.9-10.7). OS was statistically significant, demonstrating a 30 percent reduction in the risk of death with tisotumab vedotin compared with chemotherapy (Hazard ratio [HR]: 0.70 [95 percent CI: 0.54, 0.89], two-sided p=0.0038). At 12 months, OS was 48.7% in the tisotumab vedotin group (n=123/253 events/patients; 95% CI: 41.0-55.8) and 35.3% in the chemotherapy group (n=140/249 events/patients; 95% CI: 28.0-42.7). 6
Based on a safety population of 425 patients at a median duration of 3.7 months, the most common adverse reactions with tisotumab vedotin (≥25%) were peripheral neuropathy (39%), nausea (37%), epistaxis (33%), conjunctivitis (32%), alopecia (31%), anaemia (27%) and diarrhoea (25%). Serious adverse reactions occurred in 37% of patients. The most common serious adverse reactions were abdominal pain (2%), constipation (2%), pyrexia (2%), peripheral neuropathy (2%), and vomiting (2%). Fatal adverse reactions occurred in 2% of patients. 7
The key secondary endpoints were progression-free survival and confirmed objective response rate. Other endpoints were time to response and duration of response.
The study was conducted by Seagen, which was acquired by Pfizer in December 2023, in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT, study number ENGOT cx-12) and the Gynecologic Oncology Group (GOG) Foundation (study number GOG 3057), as well as other global gynaecological oncology cooperative groups. More information about the Phase 3 innovaTV 301 clinical trial can be found at [this website is not owned or managed by Genmab] www.clinicaltrials.gov.
About Tisotumab Vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) authorised under the brand name TIVDAK ® in the European Union, Japan, United Kingdom, and the United States.
Tisotumab vedotin is composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilises a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalisation of the ADC-TF complex and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity. 6 , 8
Tisotumab vedotin is co-developed and co-commercialised globally by Genmab and Pfizer, under an agreement in which the companies share costs and profits.
▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores. Adverse events should also be reported to Genmab at +44 2045792977 or at EURmedinfo@genmab.com. By reporting side effects, you can help provide more information on the safety of this medicine.
Please refer to the TIVDAK Summary of Product Characteristics for further details of this product.
About Genmab
Genmab is an international biotechnology company with a core purpose of improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, the company has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators, and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with its antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe, and Asia Pacific.
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References
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1 National Institute for Health and Care Excellence (NICE). Tisotumab vedotin for treating recurrent or metastatic cervical cancer that has progressed on or after systemic treatment [ID3753]. Final Draft Guidance. Available at : https://www.nice.org.uk/guidance/gid-ta10620/documents/674 Last accessed: May 2026
2 Cancer Research UK. Cervical cancer statistics: incidence projections to 2040 – Cancer Research UK; 2024. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/cervical-cancer Last Accessed: February 2026
3 University College London Hospitals NHS Foundation Trust. Better use of existing drugs increases cervical cancer survival and reduces recurrence. Available at: https://www.Better use of existing drugs increases cervical cancer survival and reduces recurrence: University College London Hospitals NHS Foundation Trust. Last Accessed: February 2026
4 Ghosh et al. Assessing global trends of cervical cancer: 1990-2021. J Clin Oncol. 43, e17510-e17510.
5 Cancer Research UK. Cervical cancer statistics: mortality – Cancer Research UK; 2024. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/cervical-cancer/mortality. Last Accessed: February 2026
6 Vergote I, González-Martín A, Fujiwara K, et al. innovaTV 301: Tisotumab vedotin as second- or third-line therapy for recurrent cervical cancer. N Engl J Med. 2024;391:44–55
7 Medicines & Healthcare Products Regulatory Agency. Tivdak (tisotumab vedotin) Summary of Product Characteristics.
8 de Goeij BECG, Satijn D, Freitag CM, et al. High turnover of tissue factor enables efficient intracellular delivery of antibody-drug conjugates. Mol Cancer Ther. 2015;14(5):1130-1140