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FDA Grants Priority Review For Kite's KTE-X19 BLA - Quick Facts

Kite, a Gilead Co. (GILD), said that the U.S. Food and Drug Administration has accepted the Biologics License Application and granted Priority Review designation for KTE-X19, an investigational chimeric antigen receptor or CAR T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma or MCL. The Prescription Drug User Fee Act, or target action date, is August 10, 2020.

The BLA is supported by data from the single arm, open-label, 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, as assessed by an Independent Radiologic Review Committee.

In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred.

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