Zanidatamab approved for NHS use by NICE
In April 2026, the National Institute for Health and Care Excellence (NICE) has published guidance recommending routine NHS use of zanidatamab for patients with HER2-positive advanced biliary tract cancers such as cholangiocarcinoma (bile duct cancer), gallbladder cancer, and cancer originating in the ampulla of Vater.
What does this mean?
NICE is responsible for assessing new medicines and making recommendations about whether they should be adopted for routine use by the NHS in England, based upon their cost and how effective they are.
Following their assessment, NICE has decided there is enough evidence to show that that zanidatamab provides benefits and “value for money” for the NHS.
This means that zanidatamab must be funded and available for eligible patients in the NHS in England within 90 days of the publication of NICE’s guidance.
What about Scotland, Wales and Northern Ireland?
- In Scotland, the Scottish Medicines Consortium (SMC) assesses drugs to decide whether they will be funded by the NHS. This is a separate process from NICE so they may reach a different decision. The SMC has not yet begun an assessment of zanidatamab.
- In Wales, when NICE recommends use of a treatment, their NHS must usually provide funding and resources for it within 60 days of the publication of NICE’s guidance.
- In Northern Ireland, the Department of Health, Social Services and Public Safety (DHSSPS) look at NICE guidance to decide whether to follow their decision. Usually, the NICE guidance is followed.
What is zanidatamab?
Zanidatamab is a new treatment that targets a specific gene fault, known as HER2, that is found in some tumours and encourages the cancer to grow quickly. HER2 is present in up to 1-in-10 cholangiocarcinomas and up to 1-in-5 gallbladder cancers.
Zanidatamab is typically given by a drip into a vein (intravenous infusion) once every two weeks in a hospital or clinic.
Zanidatamab may be suitable for patients who meet all the following criteria:
- the disease is locally advanced, can’t be removed through surgery, or has spread (metastasised).
- the disease has progressed after receiving first-line therapy – usually the combination chemotherapy and immunotherapy gemcitabine, cisplatin and durvalumab (GEM/CIS/DURVA).
- the tumour has a high expression of HER2, defined as IHC3 positive (approximately 4-in-5 people with HER2 positive tumours will be IHC3 positive).
In clinical trial data submitted to NICE by the pharmaceutical company, patients treated with zanidatamab survived an average of 18.1 months in comparison to 6.2 months for those receiving current second-line treatment (the chemotherapy, FOLFOX).
AMMF’s reaction to the announcement
Helen Morement, CEO of AMMF, said:
“AMMF welcomes NICE’s positive recommendation of zanidatamab. Until now, people with HER2-positive cholangiocarcinoma (bile duct cancer), gallbladder cancer, or ampullary cancer whose disease had progressed on first-line therapy had no targeted treatment options.
“During NICE’s appraisal, we heard from patients and their families about the positive difference zanidatamab provided for them. We are therefore pleased that more people with advanced HER2-positive disease will be able to access this life-extending treatment through the NHS.”
Acknowledgements
AMMF is extremely grateful to all the individuals and families who shared their experiences and supported our evidence submissions for this NICE appraisal.
AMMF submitted written evidence and comments from patients and their families, and we contributed the experiences of our community during the NICE committee meetings for the assessment of this treatment.
