Published

May 11, 2025

Zanubrutinib monotherapy [ZAN4]

For the treatment of patients with previously treated chronic lymphatic leukaemia where the following criteria have been met:

  1. This application for zanubrutinib is being made by and the first cycle of this systemic anti-cancer therapy with zanubrutinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti- cancer therapy.
  2. The patient has been previously diagnosed with chronic lymphatic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
  3. The patient has been tested for 17p deletion and for TP53 mutation and the results are as shown below:
  • negative for both 17p deletion and TP53 mutation
  • positive for 17p deletion and negative for TP53 mutation or
  • negative for 17p deletion and positive for TP53 mutation or
  • positive for both 17p deletion and TP53 mutation
  1. The patient has symptomatic disease which requires systemic therapy.
  2. The patient has been previously treated with systemic therapy for CLL/SLL.
  3. The patient is treatment naïve to a Bruton’s kinase inhibitor or the patient has been previously commenced on ibrutinib or acalabrutinib monotherapy for previously treated CLL/SLL and the ibrutinib or acalabrutinib has had to be discontinued solely due to dose-limiting toxicity and in the clear absence of disease progression or the patient has previously been treated with the 1st line combination of ibrutinib plus venetoclax and was still in response on completion of treatment but has since relapsed and this application will be the first use of a BTK inhibitor since the 1st line combination of ibrutinib plus venetoclax. Please mark which of the 4 scenarios below applies to this patient:
  • the patient has not received any previous therapy for CLL/SLL with a Bruton’s kinase inhibitor or
  • the patient previously commenced acalabrutinib for relapsed/refractory CLL/SLL and acalabrutinib has had to be stopped solely due to dose-limiting toxicity and in the clear absence of disease progression or
  • the patient previously commenced ibrutinib for relapsed/refractory CLL/SLL and ibrutinib has had to be stopped solely due to dose-limiting toxicity and in the clear absence of disease progression or
  • the patient has previously been treated with the 1st line combination of ibrutinib plus venetoclax and was still in response on completion of treatment but has since relapsed and this application will be the first use of a BTK inhibitor since the 1st line combination of ibrutinib plus venetoclax
  1. The patient has an ECOG performance status of 0 or 1 or 2.
  2. Use of zanubrutinib in this indication will be as monotherapy. Note: zanubrutinib is not licensed in CLL to be used in combination with any other agent.
  3. The prescribing clinician is aware that zanubrutinib has clinically significant interactions with cytochrome P450 enzyme 3A (CYP3A) inhibitors and inducers as described in zanubrutinib’s Summary of Product Characteristics.
  4. Zanubrutinib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment, whichever is the sooner.
  5. A formal medical review as to whether treatment with zanubrutinib should continue or not will be scheduled to occur at least by the end of the first 12 weeks of treatment.
  6. When a treatment break of more than 12 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
  7. Zanubrutinib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 20 February 2024

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA931 (22 November 2023)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 13 May 2025 at 19:45.

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.