Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved venetoclax for reimbursement as a monotherapy treatment option for the treatment of patients with chronic lymphocytic leukemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.

This is written in the approval document as:

Treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.

Reimbursement

CDS

Citation

Venetoclax Monotherapy, 2021, version number 3, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6973/400_v3_Venetoclax_Monotherapy.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	Venetoclax
HSE (1)	TP53 deletion	Chronic Lymphocytic Leukemia	Venetoclax
HSE (1)	17p deletion	Chronic Lymphocytic Leukemia	Venetoclax

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2018-12-01	Health Service Executive	Indication approved for reimbursement.