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.
You may also be interested in...
ASH Ends With Consistent Kite CAR-T Data, Some Hope For Juno
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, Kite Neck-And-Neck In CAR-T Race; Deaths Keep Juno In Third Place
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 Stresses Differences Between Its CAR-Ts As JCAR015 Trial Put On Hold Again
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.