Regulatory approval

Published by the European Medicines Agency. Approved

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 is written in the approval document as:

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.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	CD19 +	Acute Lymphoblastic Leukemia	Blinatumomab
EMA (1)	CD19 +, not BCR::ABL1	Acute Lymphoblastic Leukemia	Blinatumomab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2020-12-22	European Medicines Agency	Indication received approval from the European Commission.