Gilead's Kite announced that the U.S. FDA has accepted the Biologics License Application (BLA) and granted Priority Review designation for KTE-X19, an investigational CAR-T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
MCL is a rare form of non-Hodgkin lymphoma that arises from cells originating in the “mantle zone” of the lymph node and typically affects men over the age of 60.
The BLA is supported by data from the Phase 2 ZUMA-2 trial, which showed that 93 percent of patients responded to a single infusion of KTE-X19, including 67 percent of patients achieving a complete response. The drug's PDUFA date is August 10, 2020.
In 2017, the FDA approved Kite's Yescarta to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment.
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