Regulators have granted Kite Pharma’s Biologics License Application (BLA) Priority Review for KTE-X19, an investigational 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% of patients responded to a single infusion of KTE-X19, including 67% 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% 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 Ken Takeshita, 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.”
KTE-X19 is 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.
The European Medicines Agency recently validated the Marketing Authorization Application for KTE-X19 in the European Union.