Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved venetoclax for reimbursement as a monotherapy treatment option for the treatment of patients with chronic lymphocytic leukemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.
This is written in the approval document as:
Treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.
Citation
Venetoclax Monotherapy 2021, version number 3, NCCP National SACT Regimen, NCCP, viewed 18/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/leukemia-bmt/400.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 | Venetoclax | |
| Sensitivity (+) | TP53 deletion | Chronic Lymphocytic Leukemia | Venetoclax | |
| Sensitivity (+) | 17p deletion | Chronic Lymphocytic Leukemia | Venetoclax |