Regulatory approval

Published by the European Medicines Agency. Approved

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).

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 provided a new indication for Blincyto (blinatumomab).
2025-01-23	European Medicines Agency	Indication received approval from the European Commission.