Regulatory approval

Published by the Health Service Executive. Approved

As monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), who are treatment naive and have del(17p) and/or TP53-mutated disease.

This is written in the approval document.

Reimbursement

CDS

Citation

Zanubrutinib Therapy, 2023, version number 2, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6535/708_v2_Zanubrutinib.pdf

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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 Zanubrutinib
HSE (1) TP53 deletion Chronic Lymphocytic Leukemia Zanubrutinib
HSE (1) not 17p deletion Chronic Lymphocytic Leukemia Zanubrutinib