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.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | TP53 somatic variants | Chronic Lymphocytic Leukemia | Zanubrutinib | |
| Sensitivity (+) | TP53 deletion | Chronic Lymphocytic Leukemia | Zanubrutinib | |
| Sensitivity (+) | 17p deletion | Chronic Lymphocytic Leukemia | Zanubrutinib |