FDA accepts Kite's KTE-X19 for priority review

Gilead Sciences (Nasdaq: GILD) subsidiary Kite on Tuesday announced that the US Food and Drug Administration has accepted the Biologics License Application (BLA) and granted Priority Review designation for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

The BLA is supported by data from the single arm, open-label, Phase II ZUMA-2 trial, which showed that 93% of patients responded to a single infusion of KTE-X19, including 67% of trial subjects achieving a complete response, as assessed by an Independent Radiologic Review Committee (IRRC; median follow-up of 12.3 months). In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15% and 31% of patients, respectively. No Grade 5 CRS or neurologic events occurred.

“Despite recent advances, patients with relapsed/refractory mantle cell lymphoma currently face a significant lack of effective treatment options once their disease no longer responds to currently available therapy,” said Dr Ken Takeshita, Kite’s global head of clinical development, adding: “Based on the encouraging results for KTE-X19, we are eager to continue discussions with the FDA on how to bring this innovative treatment to these patients who may benefit from CAR T therapy.”