Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Asciminib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.
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 statement is based on a regulatory approval from the Health Service Executive:
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).
Citation
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. |