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.
Shares of $KITE were up over 5% on the news this morning.
The preliminary 3-month KTE-C19 data Belldegrun was ready to file with was clearly positive, but received mixed reviews last month among a vocal crowd of skeptics on Twitter who zeroed in on the declining response rates tracked among patients. Investors will look at the new 6 month data, due in Q1 2017, and watch for any potential drops in efficacy from the 3 month mark.
$KITE still has to produce good/durable 6 month data, but positive FDA guidance nonetheless. Bears were hoping for a 3Q17 or later filing.
— Brad Loncar (@bradloncar) November 9, 2016
The company is targeting potential approval and commercial launch of KTE-C19 in the latter half of 2017. Belldegrun noted: “We are making history with each step we take toward bringing engineered T-cell therapy to patients. We are very pleased with the outcome from our productive discussions with the FDA and their willingness to partner with us to advance this innovative therapy.”