Blincyto (blinatumomab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Amgen, Inc. Blincyto (blinatumomab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557Orig1s028Correctedlbl.pdf. Revised June 2024. Accessed October 30, 2024.

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Regulatory approvals

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

Indication Statements
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. 1
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). 1
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. 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 (+) CD19 + Acute Lymphoid Leukemia Blinatumomab
Sensitivity (+) BCR::ABL1, CD19 + Acute Lymphoid Leukemia Blinatumomab