Regulatory approval

Published by the Health Service Executive. Approved

As a single agent for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

This is written in the approval document.

Reimbursement

CDS

Citation

Ibrutinib Therapy CLL / Waldenstroms Macroglobulinaemia, 2022, version number 5, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6952/296_v5_Ibrutinib_CLL_WM.pdf

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
HSE (1) TP53 Somatic variants Chronic Lymphocytic Leukemia Ibrutinib
HSE (1) TP53 deletion Chronic Lymphocytic Leukemia Ibrutinib
HSE (1) not 17p deletion Chronic Lymphocytic Leukemia Ibrutinib