Zanubrutinib [ZAN6]

For the treatment of patients with relapsed/refractory mantle cell lymphoma in patients who have received only 1 prior line of systemic therapy where the following criteria have been met:

1. This application is being made by and the first cycle of 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 a confirmed histopathological diagnosis of mantle cell lymphoma.
3. The patient has previously been treated with one and only one prior line of rituximab-containing chemotherapy. Note: Patients treated with more than 1 line of prior therapy are not eligible for treatment with zanubrutinib.
4. The presence of relapsed/refractory mantle cell lymphoma with documented progression of disease during or following rituximab-containing 1st line systemic therapy.
5. The patient has never received any prior therapy with a BTK inhibitor (ibrutinib or zanubrutinib or another BTK inhibitor) unless the patient has either received zanubrutinib via a company early access scheme and all other treatment criteria on this form apply or the patient has suffered unacceptable toxicity on therapy with ibrutinib without any evidence of disease progression and is transferring to treatment with zanubrutinib. Please enter below which of these scenarios applies to this patient:

• the patient is treatment-naïve to a BTK inhibitor or
• the patient has received zanubrutinib via a company early access scheme and all other treatment criteria on this form apply or
• the patient has been receiving line therapy with ibrutinib but has suffered unacceptable toxicity without any evidence of disease progression and is transferring to treatment with zanubrutinib.

6. Zanubrutinib is to be used as a single agent.
7. Zanubrutinib is to be continued until disease progression, unacceptable toxicity or the patient’s choice to stop treatment.
8. The patient’s ECOG performance status is 0 or 1 or 2.
9. The patient is not on concurrent therapy with warfarin.
10. The prescribing clinician I am 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.
11. When a treatment break of more than 6 weeks beyond the expected cycle length occurs, the prescribing clinician will complete a treatment break approval form to restart treatment.
12. Zanubrutinib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 27 June 2025

Additional information

Form version:

CDF Managed Access: No

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.367 of the CDF list, downloaded from NHS England’s website on 27 June 2025 at 18:00.

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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