Kite/Gilead submits BLA to FDA for KTE X19 to treat relapsed or refractory mantle cell lymphoma.

Kite, a Gilead Company announced that it has submitted a Biologics License Application (BLA) to the FDA for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

The BLA submission is based on data from the Phase II ZUMA-2 trial, which demonstrated an overall response rate of 93 percent, including 67 percent with complete response, as assessed by an Independent Radiologic Review Committee (IRRC) following a single infusion of KTE X19. 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. Detailed findings from this trial were recently presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando.