Kite Reports Submission of BLA to the US FDA for its Second CAR T Cell Therapy

 Kite Reports Submission of BLA to the US FDA for its Second CAR T Cell Therapy

Kite Reports Submission of BLA to the US FDA for its Second CAR T Cell Therapy

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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