Blincyto (blinatumomab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.	2
BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.	1
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.	1
BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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