Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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 +, not BCR::ABL1	Acute Lymphoblastic Leukemia	Blinatumomab

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