The Food and Drug Administration (FDA) has approved Blincyto (blinatumomab; Amgen) for the treatment of patients with relapsed or refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL).

Blincyto is a bispecific T-cell engager (BiTE) antibody construct, a first-in-class immunotherapy for this condition. It works by engaging the body’s T-cells to destroy leukemia cells. It acts as a connector between CD19, which is found on most B-cell lymphoblast surfaces, and CD3, which is found on T-cell lymphocytes.

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The safety and efficacy of Blincyto were studied in 185 adults with Philadelphia (-) relapsed or refractory B-cell ALL.After treatment with Blincyto for at least four weeks, 32% of patients showed complete remission for approximately 6.7 months.

Blincyto was granted breakthrough therapy designation, priority review, and orphan product designation. It is being approved under the FDA’s accelerated approval pathway with a Risk Evaluation and Mitigation Strategy (REMS).

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