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.

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).

Citation

Amgen Europe B.V. Blincyto (blinatumomab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf. Revised July 2025. Accessed August 29, 2025.