Ibrutinib in combination with venetoclax [IBR11]

For the 1st line treatment of previously untreated chronic lymphatic leukaemia where the following criteria have been met:

1. This application for ibrutinib in combination with venetoclax is being made by and the first cycle of ibrutinib plus venetoclax 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 or small lymphocytic lymphoma.
3. The patient has been tested for 17p deletion and TP53 mutation. Please indicate the result of these tests below:

• Negative for 17p deletion and negative for TP53 mutation
• Positive for 17p deletion and negative for TP53 mutation
• Negative for 17p deletion and positive for TP53 mutation
• Positive for 17p deletion and positive for TP53 mutation

4. The outcome of IGHV mutation testing if known: Please indicate the result of this test below:

• IGHV unmutated
• IGHV mutated
• IGHV testing result not known or not done

5. The patient has symptomatic disease which requires systemic therapy.
6. The patient is treatment naïve for any systemic therapy for CLL/SLL i.e. ibrutinib and venetoclax treatment will be 1st line treatment.
7. The patient has an ECOG performance status of 0 or 1 or 2.
8. Ibrutinib will be given in combination with venetoclax and that the venetoclax will only be commenced after the patient has completed the first 3 x 4-weekly cycles of ibrutinib, i.e., addition of venetoclax at cycle 4.
9. Before the start of venetoclax therapy the patient will be prospectively assessed for the risk of the development of tumour lysis syndrome with venetoclax and that appropriate risk mitigation strategies will be put in place.
10. The patient has been assessed specifically for potential drug interactions with venetoclax.
11. The maximum treatment duration of ibrutinib in this indication is for a maximum of 15 x 4-weekly cycles.
12. The maximum treatment duration of venetoclax in this indication is for a maximum of 12 4-weekly cycles.
13. Ibrutinib plus venetoclax are to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment or for the maximum treatment duration of 15 cycles of ibrutinib and 12 cycles of venetoclax.
14. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
15. Ibrutinib and venetoclax will be otherwise used as set out in their respective Summary of Product Characteristics (SPCs).

[NHS funded]{.badge .rounded-pill .bg-success} From: 29 August 2023

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CDF Managed Access: NA

NICE Technology Appraisal: TA891 (31 May 2023)

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