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 adult patients with Philadelphia chromosome negative CD19 positive B-cell precusor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
This statement is based on a regulatory approval from the European Medicines Agency:
BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.