Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved acalabrutinib (tablets) for reimbursement as a monotherapy treatment option for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL) in the presence of 17p deletion or TP53 mutation who are unsuitable for chemoimmunotherapy.
This is written in the approval document as:
As monotherapy for the treatment of previously untreated CLL in the presence of 17p deletion or TP53 mutation in adult patients unsuitable for chemoimmunotherapy.
Citation
Acalabrutinib (Tablets) Monotherapy, 2023, version number 1a, NCCP National SACT Regimen, NCCP, viewed 18/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/leukemia-bmt/840-acalabrutinib-tablets-monotherapy.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 | Acalabrutinib | |
| Sensitivity (+) | TP53 deletion | Chronic Lymphocytic Leukemia | Acalabrutinib | |
| Sensitivity (+) | 17p deletion | Chronic Lymphocytic Leukemia | Acalabrutinib |