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Pharmaceuticals / Submissions and Approvals

FDA Grants Breakthrough Therapy Designation to Novartis’s CAR-T Cell Therapy CTL019

April 24, 2017

The FDA granted a breakthrough therapy designation to Novartis’s CTL019, a chimeric antigen receptor T cell immunotherapy, or CAR-T, for the treatment of adult patients with relapsed and refractory diffuse large B-cell lymphoma that have failed two or more prior therapies.

During the treatment process, T cells are drawn from a patient's blood and reprogrammed in the laboratory to create T cells that are genetically coded to hunt the patient's cancer cells and other B-cells expressing a particular antigen.

The FDA accepted the company's biologics license application filing and granted priority review for CTL019 in the treatment of pediatric and young adult patients with B-cell ALL. This is the second indication for which CTL019 has received this designation.

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