Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved blinatumomab for reimbursement as a monotherapy treatment option for the treatment of pediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
This is written in the approval document as:
As monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation
Citation
Blinatumomab Paediatric Therapy, 2019, version number 1, NCCP National SACT Regimen, NCCP, viewed 03/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/p567-blinatumomab-paediatric-therapy.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | BCR::ABL1, CD19 + | Acute Lymphoid Leukemia | Blinatumomab |