Kite gives itself a little more time to finish FDA application for KTE-C19
Kite Pharma has given itself until Q1 2017 to complete the BLA filing for KTE-C19, its pioneering engineered T-cell therapy. That’s a slight pushback of the original schedule outlined by CEO Arie Belldegrun, who last month set a goal to finish the submission by the end of 2016.
Eager to cement first-mover in CAR-T, Belldegrun was ready to go with positive three-month results for the therapy in advanced diffuse large B-cell lymphoma (DLBCL). Now the company says it’ll begin the BLA submission by the end of December, which will give it time to submit 6-month data from its ZUMA-1 pivotal trial.
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