Acalabrutinib (Tablets) Monotherapy. NCCP National SACT Regimen. HSE.

Regulatory approval published by the Health Service Executive.

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

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
As monotherapy for the treatment of previously untreated CLL in the presence of 17p deletion or TP53 mutation in adult patients unsuitable for chemoimmunotherapy. 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HSE (1) TP53 somatic variants Chronic Lymphocytic Leukemia Acalabrutinib
HSE (1) TP53 deletion Chronic Lymphocytic Leukemia Acalabrutinib
HSE (1) 17p deletion Chronic Lymphocytic Leukemia Acalabrutinib