Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved idelalisib in combination with rituximab for reimbursement as a treatment option for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) who are not eligible for any other therapies and whose tumors have 17p deletion or TP53 mutated disease.
This is written in the approval document as:
In combination with riTUXimab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.
Citation
Idelalisib and riTUXimab Therapy, 2023, 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/idelalisib-and-rituximab-v2-389.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 | Idelalisib, Rituximab | |
| Sensitivity (+) | TP53 deletion | Chronic Lymphocytic Leukemia | Idelalisib, Rituximab | |
| Sensitivity (+) | 17p deletion | Chronic Lymphocytic Leukemia | Idelalisib, Rituximab |