Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that CD19 + and not BCR::ABL1 status confers therapeutic sensitivity to Blinatumomab in patients with Acute Lymphoid Leukemia.
The European Medicines Agency (EMA) has authorized Blincyto (blinatumomab) as a monotherapy treatment option as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philidelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL).
This statement is based on a regulatory approval from the European Medicines Agency:
BLINCYTO is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precusor acute lymphoblastic leukaemia (ALL).