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 high-risk first relapsed Philidelphia chromosome negative CD19 positive B-cell precursor ALL as part of the consolidation therapy.

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 high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy.

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