New Interim CAR-T Data Support Kite’s BLA Submission Plans
Kite Pharma Inc. executives reiterated plans on Sept. 26 to pursue US FDA approval this year for the chimeric antigen receptor T cell (CAR-T) therapy known as KTE-C19, keeping the company on track to seek accelerated approval for a form of advanced lymphoma before any of its competitors.
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Kite reported interim results for KTE-C19 from the ZUMA-1 study that showed efficacy consistent with earlier results without the deaths from neurotoxicity that have plagued Juno, but Juno’s latest CAR-T offering may carry fewer safety concerns.
Novartis and Kite both are set to submit their CD19-targeting CAR-T therapies for US FDA approval in early 2017, while neurotoxic deaths for two of Juno’s product candidates cast doubts on its programs.
Juno stressed structural differences, safety record and potential of its JCAR017 CAR-T therapy during a Nov. 23 call about the disappointing hold on its ROCKET ALL study for JCAR015 – the second clinical hold for the company’s most advanced development program.