Kite, a Gilead Company announced that the U.S. Food and Drug Administration (FDA) 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 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 (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 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred. Detailed findings from this trial were recently presented during an oral session at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando.
“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 Ken Takeshita, MD, Kite’s Global Head of Clinical Development. “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.”
The Prescription Drug User Fee Act (PDUFA), or target action date, is August 10, 2020. The European Medicines Agency (EMA) recently validated the Marketing Authorization Application for KTE-X19 in the European Union. KTE-X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) designation by the EMA for relapsed or refractory MCL.
KTE-X19 is investigational and not yet approved in any country globally. Its efficacy and safety have not been established. A final decision by the FDA is anticipated by August.