Novartis cell treatment named \"breakthrough therapy\" in US

FDA

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, 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.

For more details, go to: http://uk.reuters.com/article/2014/07/07/novartis-drug-idUKL6N0PI4W720140707

Michael Wonder

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Michael Wonder

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