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 high-risk first relapsed Philidelphia chromosome negative CD19 positive B-cell precursor ALL as part of the consolidation therapy.
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 high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy.