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Novartis cell treatment named "Breakthrough Therapy" in US
July 7, 2014 / 5:50 PM / 3 years ago

Novartis cell treatment named "Breakthrough Therapy" in US

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ZURICH, July 7 (Reuters) - Swiss drugmaker Novartis said on Monday U.S. health regulators have granted its personalised cell therapy CLT019 "Breakthrough Therapy" status, meaning the treatment will be fast-tracked within the U.S. regulatory system.

The U.S. Food and Drug Administration's "Breakthrough Therapy" designation aims to speed up the review process of medicines that treat serious or life-threatening conditions.

Together with the University of Pennsylvania's Perelman School of Medicine (Penn), Novartis is developing CTL019 as a treatment for patients both young and old with relapsed/refractory acute lymphoblastic leukemia.

CTL019, which is currently in Phase I/II clinical trials, works by engineering a patient's own T-cells to hunt and attack cancer cells that express a specific protein called CD19.

Novartis leads the field at present with these Chimeric Antigen Receptor T-cell, or CAR-T, immunotherapies, and has products in clinical trials for leukaemia, lymphoma, mesothelioma and pancreatic cancer.

Reporting by Caroline Copley. Editing by Jane Merriman

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