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 European Medicines Agency (EMA) has authorized Blincyto (blinatumomab) as a monotherapy for the treatment of pediatric patients aged 1 year or older with Philidelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplants.
This statement is based on a regulatory approval from the European Medicines Agency:
BLINCYTO is indicated 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 haematopoietic stem cell transplantation.