Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved ibrutinib for reimbursement as a monotherapy, first-line treatment option for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who are unsuitable for chemoimmunotherapy and whose tumors have 17p deletion or TP53 mutated disease.
This is written in the approval document as:
As a single agent for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
Citation
Ibrutinib Therapy CLL / Waldenstroms Macroglobulinaemia, 2022, version number 5, NCCP National SACT Regimen, NCCP, viewed 18/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/leukemia-bmt/296.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 | Ibrutinib | |
| Sensitivity (+) | TP53 deletion | Chronic Lymphocytic Leukemia | Ibrutinib | |
| Sensitivity (+) | 17p deletion | Chronic Lymphocytic Leukemia | Ibrutinib |