|
 The FDA's announcement late Wednesday means the regulator plans to
take action within six months on Novartis's so-called chimeric
antigen receptor T cell therapy, or CAR-T, in partnership with
University of Pennsylvania researchers.
The medicine, called CTL019, is a treatment for young patients with
B-cell acute lymphoblastic leukemia.
Novartis shares were little changed on Thursday, but UK-based Oxford
BioMedica, which makes ingredients for CTL019 and will reap
undisclosed royalties from future sales, rose more than 4.5 percent
on the announcement.
The therapy involves taking a patient's own T-cells, altering them
in the lab to help the immune system find and kill cancer cells, and
then re-infusing them into the patient.
Basel-based Novartis is now in pole position with regulators as it
pushes for approval alongside rivals including biotech Kite Pharma
Inc that are developing similar therapies.
"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.
Analysts do not expect significant sales to materialize quickly,
however, due in part to the challenging process necessary to
extract, re-engineer and re-infuse T cells for each patient.
[to top of second column] |
This complexity is among factors that will "likely constrain
commercial implications for CTL019 near term," wrote Emmanuel
Papadakis, a Barclays analyst who expects the therapy to win
approval in the third quarter and to be launched in early 2018.
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 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 this year. It also
plans eventually to seek approval for CTL019 to be used in patients
with certain types of relapsed or refractory non-Hodgkin lymphoma,
another type of blood cancer.
(Reporting by John Miller; Editing by Mark Potter)
[© 2017 Thomson Reuters. All rights
reserved.] Copyright 2017 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
