Annotation of EMA Label for blinatumomab and CD19
PharmGKB ID
Summary
The EMA-approved drug label for blinatumomab (BLINCYTO) states that it is indicated for treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). The mechanism of action of blinatumomab is via CD19, and all indications for treatment with blinatumomab require CD19-positive status. The label states that CD19-negative B-cell precursor ALL has been reported in relapsed patients receiving blinatumomab, and that particular attention should be given to assessment of CD19 expression at the time of bone marrow testing.
Annotation
Excerpts from the blinatumomab (BLINCYTO) EPAR:
Blinatumomab is a bispecific T-cell engager molecule that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T-cells. It activates endogenous T-cells by connecting CD3 in the T-cell receptor (TCR) complex with CD19 on benign and malignant B-cells. ... Blinatumomab is associated with transient upregulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T-cells, and results in elimination of CD19+ cells.
CD19-negative B-cell precursor ALL has been reported in relapsed patients receiving BLINCYTO. Particular attention should be given to assessment of CD19 expression at the time of bone marrow testing.
For the complete EPAR text with sections containing pharmacogenetic information highlighted, see the blinatumomab EPAR PDF.
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Evidence for Clinical Annotations
This annotation has been used as evidence for the following clinical annotations.
History
No history available.