ZURICH, July 7 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.
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)