Ibrutinib monotherapy [IBR9]

Ibrutinib monotherapy for the treatment of patients with chronic lymphatic leukaemia which has a 17p deletion or TP53 mutation where the following criteria have been met:

1. This application for ibrutinib is being made by and the first cycle of this systemic anti-cancer therapy with ibrutinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has been diagnosed with chronic lymphatic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
3. The patient has been tested for 17p deletion and preferably for TP53 mutation as well and the results are positive for either 17p deletion or TP53 mutation or both. Please indicate the result of these tests below:

• positive for 17p deletion and not tested for TP53 mutation or
• 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.

4. The patient has symptomatic disease which requires systemic therapy.
5. The patient has not received any previous BTK inhibitor therapy for CLL/SLL unless 1st line acalabrutinib or 1st line zanubrutinib has had to be stopped as a consequence of dose-limiting toxicity and in the clear absence of disease progression. Please mark which of the 3 scenarios below applies to this patient:

• the patient has not received any previous BTK inhibitor therapy for CLL/SLL or
• the patient previously commenced 1st line acalabrutinib and the acalabrutinib has had to be stopped solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression
• the patient previously commenced 1st line zanubrutinib and the zanubrutinib has had to be stopped solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression

6. The patient has an ECOG performance status of 0 or 1 or 2. 7.Use of ibrutinib in this indication will be as monotherapy.
7. The prescribing clinician is aware that ibrutinib should not be administered concomitantly with warfarin or other vitamin K antagonists and that ibrutinib has clinically significant interactions with CYP3A4 inhibitors and inducers (see ibrutinib’s Summary of Product Characteristics).
8. Ibrutinib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment, whichever is the sooner.
9. A formal medical review as to whether treatment with ibrutinib should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
10. When 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, including as appropriate if the patient had an extended break on account of Covid-19.
11. Ibrutinib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 25 April 2017

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA429 (25 January 2017)

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 08 May 2025 at 22:10.

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.