Zanubrutinib [ZAN5]

Zanubrutinib monotherapy for the treatment of patients with marginal zone lymphoma treated with at least 1 prior anti-CD20-based therapy 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 a confirmed histological diagnosis of marginal zone lymphoma (MZL).
3. The patient has been previously treated with at least 1 prior anti-CD20- based regimen for MZL. Please mark below how many lines of systemic therapy the patient has received:

• the patient has had 1 prior line of systemic therapy and this contained an anti-CD20 agent or
• the patient has had 2 prior lines of systemic therapy of which at least one line of treatment contained an anti-CD20 agent or
• the patient has had 3 prior lines of systemic therapy of which at least one line of treatment contained an anti-CD20 agent or
• the patient has had 4 or more prior lines of systemic therapy of which at least one line of treatment contained an anti-CD20 agent

4. The patient’s disease has failed to respond to or has progressed following the last line of systemic therapy.
5. The patient is either treatment naïve to therapy with a Bruton’s kinase inhibitor or has been treated with zanubrutinib for previously treated MZL via a company compassionate access scheme and all other treatment criteria on this form fulfilled. are
6. The patient has an ECOG performance status of 0 or 1 or 2.
7. Use of zanubrutinib in this indication will be as monotherapy. Note: zanubrutinib is not licensed in MZL to be used in combination with any other agent.
8. The prescribing clinician is aware that zanubrutinib has clinically significant interactions with cytochrome P450 enzyme 3A (CYP3A) and other inhibitors and inducers as described in zanubrutinib’s Summary of Product Characteristics (sections 4.2 and 4.5).
9. Zanubrutinib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment, whichever is the sooner.
10. 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 8 weeks of treatment.
11. When a treatment break of more than 12 weeks beyond the expected 4-weekly cycle length is needed, I 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).

NHS funded From: 03 December 2024

Additional information

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CDF Managed Access: NA

NICE Technology Appraisal: TA1001 (04 September 2024)

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