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 Lymphoblastic 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).

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.

Contributions

Date	Contributor	Description
2025-08-29	Van Allen lab	On 2025-02-10, the EMA published an EPAR - Assessment report - Variation that provided a new indication for Blincyto (blinatumomab).
2025-01-23	European Medicines Agency	Indication received approval from the European Commission.