Regulatory approval

Published by the Health Service Executive. Approved

As monotherapy for the treatment of previously untreated CLL in the presence of 17p deletion or TP53 mutation in adult patients unsuitable for chemoimmunotherapy.

This is written in the approval document.

Reimbursement

CDS

Citation

Acalabrutinib (Tablets) Monotherapy, 2024, version number 2, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/7006/840_v2_Acalabrutinib_tablets.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	Acalabrutinib
HSE (1)	TP53 deletion	Chronic Lymphocytic Leukemia	Acalabrutinib
HSE (1)	not 17p deletion	Chronic Lymphocytic Leukemia	Acalabrutinib