| ZURICH, March 30
ZURICH, March 30 Novartis AG on
Wednesday said the U.S. Food and Drug Administration (FDA) has
agreed to accelerate its review of the Swiss drugmaker's CTL019
therapy for young patients with B-cell acute lymphoblastic
The move would keep Novartis on track with the development
of its so-called chimeric antigen receptor T cell therapy, or
CAR-T, in partnership with University of Pennsylvania
The therapy involves a patient's own T-cells being altered
in the lab to help the immune system find and kill cancer cells
before being re-infused into the patient.
Basel-based Novartis' first CAR-T therapy license
application with the FDA has put the company in pole position
with regulators as it pushes for approval alongside rivals
including biotech Kite Pharma Inc that are developing
"With CTL019, Novartis is at the forefront of the science
and development of immunocellular therapy as a potential new
innovative approach to treating certain cancers where there are
limited options," Vas Narasimhan, Novartis head of drug
development, said in a statement.
CTL019 will likely cost hundreds of thousands of dollars per
patient if approved, and Novartis counts it among drugs it
believes will eventually exceed $1 billion in annual sales.
In a Phase II study, Novartis said 82 percent of patients
infused with CAR-T cells achieved complete remission or complete
remission with incomplete blood count recovery at three months
after treatment. In December, Novartis estimated that 60 percent
of those responders were relapse-free after six months.
The company plans to submit an application for market
authorization with the European Medicines Agency (EMA) later
(Reporting by John Miller)