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 for the treatment of pediatric patients aged 1 month or older with Philidelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplants.

This statement is based on a regulatory approval from the European Medicines Agency:

BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation.

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 recommended revising this approval's from being indicated for pediatric patients aged 1 year or older to 1 month or older.
2025-01-23	European Medicines Agency	Indication received approval from the European Commission.
2024-10-20	Van Allen lab	Adding EMA approvals for use to database