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 cholangiocarcinoma. Please also indicate below whether the cholangiocarcinoma is of intrahepatic or extrahepatic origin:

• the cholangiocarcinoma is of intra-hepatic origin
• the cholangiocarcinoma is of extrahepatic origin

3. The cholangiocarcinoma 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 cholangiocarcinoma and the disease has progressed during or after such therapy. Please also indicate whether the patient has received 1 or >=2 lines of systemic therapy:

• the patient has been previously treated with 1 line of systemic therapy for cholangiocarcinoma
• the patient has been previously treated with >=2 lines of systemic therapy for cholangiocarcinoma Patients who have progressed < 6 months from completion of adjuvant therapy will be considered as having received 1 prior line of therapy for advanced disease

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.
11. Zanidatamab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 21 April 2026

Additional information

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The data on this page was produced using version 1.394 of the CDF list, downloaded from NHS England’s website on 24 April 2026 at 18:00.

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