Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BCR::ABL1, CD19 + status confers therapeutic sensitivity to Blinatumomab in patients with Acute Lymphoid Leukemia.
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 statement is based on a regulatory approval from the Health Service Executive:
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