MHRA Grants Marketing Authorisation to TIVDAK® ▼ (tisotumab vedotin) for the Treatment of Recurrent or Metastatic Cervical Cancer with Disease Progression On or After Systemic Therapy
London, United Kingdom - December 18, 2025
Genmab UK Ltd. (Nasdaq: GMAB) announced today that the United Kingdom’s (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to
TIVDAK ® ▼ (tisotumab vedotin), an antibody-drug conjugate (ADC), for the monotherapy treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. 1
Despite progress in the prevention and treatment of early-stage cervical cancer, there remains a high need for new therapies for recurrent and metastatic disease. 2, 4 , 5 Globally, cervical cancer is the fourth leading cause of cancer-related death among women. 6 In the U.K. every year, it is estimated that 3,300 women are diagnosed with cervical cancer 7 and approximately 900 women die from the disease. 8 Among those who respond to initial treatment, recurrence occurs in up to 30% of cases. 9
“Women in the U.K. living with recurrent or metastatic cervical cancer face limited treatment options and a poor prognosis following initial therapy,” said Professor Susana Banerjee, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Professor in Women's Cancers at The Institute of Cancer Research, London. “The survival benefit shown with tisotumab vedotin could help to address a critical need for eligible patients long underserved by current therapies.”
The authorisation of tisotumab vedotin was supported by data from the global, randomised, Phase 3 innovaTV 301 study (CTIS 2023-503813-31-01 / NCT04697628) 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. 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). Key secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) were also met. With 392 events (disease progression or death) having occurred, the median PFS was 4.2 months in the tisotumab vedotin group (95% CI: 4.0-4.4) and 2.9 months in the chemotherapy group (95% CI: 2.6-3.1). PFS results were statistically significant with tisotumab vedotin, demonstrating a 33% reduction in the risk of disease worsening or death compared with chemotherapy (HR: 0.67 [95 percent CI: 0.54-0.82], two-sided p<0.001). At six months, PFS was 30.4% in the tisotumab vedotin group (n=198/253 events/patients; 95% CI: 24.5-36.5) and 18.9% in the chemotherapy group (n=194/249 events/patients; 95% CI: 13.8-24.7). In the study, ORR was 17.8% in the tisotumab vedotin group (95% CI: 13.3-23.1) and 5.2% in the chemotherapy group (95% CI: 2.8-8.8) (odds ratio: 4.0 [95% CI: 2.1-7.6], two-sided p<0.001). 1 , 2,3
Based on 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. 1
“The MHRA authorisation of tisotumab vedotin provides a new option for eligible women in the U.K. with recurrent or metastatic cervical cancer,” said Matt Kiely, General Manager, U.K., Genmab. “While national disease prevention and early detection efforts continue to make important strides, patients with advanced cervical cancer have faced limited options. As the first antibody-drug conjugate licensed in this setting, tisotumab vedotin could represent meaningful progress in the treatment landscape and underscores our commitment to advancing innovations that improve outcomes for women affected by gynaecological cancers. Our focus now is engaging with NICE to determine the path towards enabling access to eligible patients through the NHS.”
Please refer to the TIVDAK Summary of Product Characteristics for further details of this product.
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 was overall survival. The main secondary outcomes were progression-free survival and confirmed objective response rate.
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. 1, 10
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.
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.
Caitlin Craparo, Vice President, Global Communications & Corporate Affairs
T: +1 609 255 7397; E: cacr@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
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Genmab A/S and/or its subsidiaries own the following trademarks: Genmab ®; the Y-shaped Genmab logo ®; and Genmab in combination with the Y-shaped Genmab logo ® .. Tivdak ® is a trademark owned by Seagen Inc.
References
Clicking the links below will take you to external websites that are not managed or owned by Genmab.
1 Medicines & Healthcare Products Regulatory Agency. Tivdak (tisotumab vedotin) Summary of Product Characteristics. Available at: https://mhraproducts4853.blob.core.windows.net/docs/388aa83586399edde92df190cfb5418a32c59f21. Last Accessed: December 2025
2 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
3 ClinicalTrials.gov. A randomized, open-label, Phase 3 trial of tisotumab vedotin vs investigator's choice chemotherapy in second- or third-line recurrent or metastatic cervical cancer (innovaTV 301). Available at: https://clinicaltrials.gov/study/NCT04697628. Last Accessed: November 2025
4 World Health Organization. Global strategy to accelerate the elimination of cervical cancer as a public health problem. 2020. Available at: https://iris.who.int/server/api/core/bitstreams/4e245e89-ddcc-488f-97c7-9de5e08524ef/content. Last Accessed: November 2025
5 NHS. Treatment for cervical cancer. NHS UK. Available at: https://www.nhs.uk/conditions/cervical-cancer/treatment/. Last Accessed: November 2025
6 Wu J, Jin Q, Zhang Y, et al. Global burden of cervical cancer: current estimates, temporal trend and future projections based on the Globocan 2022. J Natl. Cancer Cent. 2025;5:322-329
7 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: November 2025
8 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: November 2025
9 University College London Hospitals NHS Foundation Trust. Better use of existing drugs increases cervical cancer survival and reduces recurrence. Available at: https://www.uclh.nhs.uk/news/better-use-existing-drugs-increases-cervical-cancer-survival-and-reduces-recurrence. Last Accessed: November 2025
10 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