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 year or older with Philidelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplants.

This is written in the approval document as:

BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year 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.

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 June 2023. Accessed March 11, 2024.

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