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.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 51,200+ biopharma pros who read Endpoints News by email every day.Free Subscription