MHRA approves tisotumab vedotin for the treatment of cervical cancer
As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 2 December 2025, approved tisotumab vedotin (Tivdak) used for the treatment of adults with cervical cancer that has come back or spread. It is used if the disease worsened after previous anti-cancer treatment.
Tisotumab vedotin is administered via an intravenous infusion (drip) into the vein over 30 minutes once every three weeks.
Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, said:
“Patient safety is our top priority.
“The approval of tisotumab vedotin provides a new treatment option for adults with cervical cancer.
“As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.”
A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), which will be published on the MHRA website within 7 days of approval.
The most common side effects include eye problems such as conjunctivitis and keratitis, and nerve problems such as numbness, tingling or burning in the hands and feet.
As with any medicine, the MHRA will keep the safety and effectiveness of tisotumab vedotin under close review. Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
ENDS
Notes to editors
-
The approval was granted on 2 December 2025 to GENMAB AS
-
This medicine has been approved through the International Recognition Procedure (IRP).
-
More information can be found in the Summary of Product Characteristics and Patient Information Leaflets which will be published on the MHRA Products website within 7 days of approval.
-
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.
-
All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
-
The MHRA is an executive agency of the Department of Health and Social Care.
-
For media enquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651.