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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