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Oncology Times:
doi: 10.1097/01.COT.0000453430.23841.38
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FDA's Breakthrough Designation to Blinatumomab and CTL019 for ALL

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The U.S. Food and Drug Administration has granted Breakthrough Therapy status to blinatumomab for the treatment of adults with Philadelphia-chromosome negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). The drug, made by Amgen, is an investigational bispecific T cell engager (BiTE) antibody designed to direct the body's cell-destroying T cells against target cells expressing CD19, found on the surface of B-cell derived leukemias and lymphomas.

Also given the status, just a few days later, was CTL019, an investigational chimeric antigen receptor (CAR) therapy, for the treatment of adult and pediatric patients with relapsed or refractory ALL. CTL019, made by Novartis, uses CAR technology to reprogram a patient's own T cells to target and destroy cancer cells that express specific CD19 proteins.

The Breakthrough Therapy designation, enacted as part of the FDA's 2012 Safety and Innovation Act, was created to expedite the development and review time of a potential new drug for serious or life-threatening disease where early clinical evidence suggests the drug may demonstrate substantial improvement compared with existing therapies.

Approximately 6,020 new cases of ALL are estimated to be diagnosed in the U.S. in 2014, according to American Cancer Society incidence statistics.

The Breakthrough Therapy designation for blinatumomab was based on the results of a Phase II trial of 189 patients with Ph- relapsed or refractory B-precursor ALL treated with the drug. Data from that trial were presented at the American Society of Clinical Oncology Annual Meeting (Abstract 7005), as well as the Congress of the European Hematology Association in June.

Wolters Kluwer Health | Lippincott Williams & Wilkins

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