On the heels of promis­ing MCL da­ta, Kite hus­tles its 2nd CAR-T to the FDA as the next big race in the field draws to the fin­ish line

Three days af­ter Gilead’s Kite sub­sidiary showed off stel­lar da­ta on their num­ber 2 CAR-T KTE-X19 at ASH, the ex­ec­u­tive team has piv­ot­ed straight to the FDA with a BLA fil­ing and a shot at a near-term ap­proval.

In a small, 74-pa­tient Phase II tri­al re­port­ed out at the be­gin­ning of the week, in­ves­ti­ga­tors tracked a 93% re­sponse rate with two out of three man­tle cell lym­phoma pa­tients ex­pe­ri­enc­ing a com­plete re­sponse.

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