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 Lymphoid Leukemia	Blinatumomab