Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved ibrutinib for reimbursement as a monotherapy, first-line treatment option for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who are unsuitable for chemoimmunotherapy and whose tumors have 17p deletion or TP53 mutated disease.

This is written in the approval document as:

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.

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

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)	17p deletion	Chronic Lymphocytic Leukemia	Ibrutinib

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2016-07-19	Health Service Executive	Indication approved for reimbursement.