Shots:

• The Kite has submitted BLA to the US FDA for its investigational CAR T cell therapy- KTE-X19 for the treatment of r/r MCL
• The BLA submission is based on P-II ZUMA-2 study assessing KTE-X19 in 74 patients aged ≥18 yrs. with r/r MCL prior treated with up to 5L therapies- demonstrating ORR (93%); CR as measured by IRRC (67%) following a single infusion of KTE-X19. The submission marks the expansion of Kite’s cell therapy portfolio
• KTE-X19 is an anti-CD19 CAR T cell therapy- currently being evaluated in P-I/II study for ALL- MCL and CLL and has received the US FDA’s BT and EMA’s PRIME designation for r/r MCL with its anticipated MAA submission in EU in H1’20

Click here to­ read full press release/ article | Ref: Gilead | Image: STAT News