Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved zanubrutinib for reimbursement as a monotherapy treatment option for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who are treatment naive and whose tumors have 17p deletion and/or TP53 mutated disease.

This is written in the approval document as:

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.

Citation

Zanubrutinib Therapy, 2023, version number 2, NCCP National SACT Regimen, NCCP, viewed 18/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/lymphoma-myeloma/708-zanubrutinib-therapy.pdf

Therapeutic response

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

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