May 26 Kite Pharma Inc on Friday said
the U.S. Food and Drug Administration will review its
experimental drug axicabtagene ciloleucel on a priority basis as
a treatment for advanced non-Hodgkin lymphoma, a cancer that
starts in white blood cells.
The drug is a chimeric antigen receptor T-cell (CAR-T)
therapy, developed using a complicated process of extracting
immune system T cells from an individual patient, altering their
DNA to sharpen their ability to spot and kill cancer cells, and
infusing them back into the same patient.
The FDA's decision is expected by Nov. 29. Kite announced in
March that it had completed the FDA filing.
Kite said the filing was supported by data showing that 82
percent of patients responded to the therapy, with 44 percent
continuing to respond after a median of 8.7 months follow up.
Two trial deaths were deemed to be related to the CAR-T drug.
Kite shares fell 2 percent to close at $73.11 on Nasdaq, but
were up 1 percent after hours. Shares of rival Juno Therapeutics
Inc slid 9 percent to end at $23.30, but were up 1.7
percent after hours.
Shares of Juno have dropped 43 percent since last June when
the company put on hold a trial of its most advanced CAR-T
therapy after patient deaths were linked to swelling in the
brain. Juno eventually shelved development of that drug.
The FDA is already reviewing another CAR-T therapy, Novartis
AG's tisagenlecleucel-T, as a treatment for pediatric
and young adult patients with relapsed/refractory B-cell acute
Clinical trial updates on a range of CAR-T therapies are
expected next month at the annual meeting of the American
Society of Clinical Oncology in Chicago.
(Reporting by Deena Beasley; Editing by David Gregorio)