Zanidatamab [ZANI1]

For the treatment of HER2-positive advanced biliary tract cancer after 1 or more lines of systemic treatment where the following criteria have been met:

1. This application for zanidatamab is being made by and the first cycle of systemic anti-cancer therapy with zanidatamab will be prescribed by a consultant, or internally accredited oncology specialty trainee, specifically trained and assessed in the use of systemic anti-cancer therapy.
2. The patient has a histologically or cytologically confirmed diagnosis of biliary tract cancer.
3. The biliary tract cancer has been tested for HER2 expression with a validated test and the result is IHC3+.
4. The patient has unresectable locally advanced or metastatic disease.
5. The patient has been previously treated with systemic therapy for biliary tract cancer and the disease has progressed during or after such therapy.
6. The patient has an ECOG performance status of 0 or 1.
7. The patient either has no known brain metastases or if the patient has brain metastases, the patient is symptomatically stable prior to starting treatment with zanidatamab.
8. Zanidatamab will be used as monotherapy.
9. The patient will be treated until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment, whichever is the sooner.
10. Where a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, which MUST be approved before treatment with zanidatamab is recommenced. will be 11. Zanidatamab otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 05 August 2026

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: TA1001 (07 May 2026)

Current Form Version

Note

The data on this page was produced using version 1.406 of the CDF list, downloaded from NHS England’s website on 09 September 2026 at 21:36.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

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• ZANI1_prior_to_cdf_1.406