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 single agent treatment option for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. The treatment regimen further describes the eligibility criteria as requiring cyclin D1 overexpression or translocation breakpoints at t(11;14).

This is written in the approval document as:

As a single agent for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

Reimbursement

CDS

Citation

Ibrutinib Therapy - Mantle Cell Lymphoma, 2022, version number 4, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/6953/297_Ibrutinib_MCL.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	t(11;14)	Mantle Cell Lymphoma	Ibrutinib
HSE (1)	CCND1	Mantle Cell Lymphoma	Ibrutinib

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2026-07-29	Health Service Executive	Indication approved for reimbursement.