FDA Grants Breakthrough Therapy Designation to Blinatumomab for Acute Lymphoblastic Leukemia


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The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to blinatumomab for adults with Philadelphia chromosome–negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

Blinatumomab is an investigational bispecific T-cell engager antibody designed to direct the body’s cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell–derived leukemias and lymphomas. Bispecific T-cell engager antibodies are a type of immunotherapy in which modified antibodies are designed to engage two different targets simultaneously, thereby placing the T cells within reach of the targeted cancer cell.

The Breakthrough Therapy designation was based on the results of a phase II trial of 189 adult patients with Philadelphia chromosome–negative relapsed/refractory B-precursor ALL treated with blinatumomab. Data from the phase II trial were most recently presented at the 50th Annual Meeting of the American Society of Clinical Oncology and the 19th Congress of the European Hematology Association.

Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The designation requires preliminary clinical evidence demonstrating that the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. ■



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