Regulatory approval
Published by the Health Service Executive. Approved
The Republic of Ireland's Health Service Executive (HSE) has approved asciminib for reimbursement as a monotherapy treatment option for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase, who have been previously treated with two or more tyrosine kinase inhibitors (TKIs). The therapy regimen further states that hypersensitivity to asciminib or to any of the excipients, presence of the T315I mutation, and pregnancy / breastfeeding are exclusion criteria.
This is written in the approval document as:
Treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase (CP), who have previously been treated with two or more tyrosine kinase inhibitors (TKIs).
Reimbursement
CDS
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HSE (1) | BCR::ABL1 | Chronic Myeloid Leukemia, BCR-ABL1+ | Asciminib |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-01-16 | Van Allen lab | Adding HSE approvals for reimbursement to database |
| 2023-11-01 | Health Service Executive | Indication approved for reimbursement. |