Regulatory approval

Published by the European Medicines Agency.

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 is written in the approval document as:

BLINCYTO is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precusor acute lymphoblastic leukaemia (ALL).

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BCR::ABL1, CD19 +	Acute Lymphoid Leukemia	Blinatumomab