Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that 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 CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.
This statement is based on a regulatory approval from the European Medicines Agency:
BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.