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