Regulatory approval
Published by the Health Service Executive.
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).
Citation
Asciminib Monotherapy, 2023, version number 1, NCCP National SACT Regimen, NCCP, viewed 16/12/2023, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/leukemia-bmt/847-asciminib-therapy.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | BCR::ABL1 | Chronic Myelogenous Leukemia | Asciminib |