Shots:

• The US FDA has accepted BLA and granted PR designation to Kite’s KTE-X19 for the treatment of patients with r/r MCL
• The BLA is based on P-II ZUMA-2 study assessing KTE-X19 in 74 patients aged ≥18yrs. with r/r MCL following up to prior 5L therapies including an anthracycline- bendamustine-containing CT- anti-CD20 mAb and the BTK inhibitors (ibrutinib/acalabrutinib)
• KTE-X19 is an investigational- autologous- anti-CD19 CAR T cell therapy- currently being evaluated in P-I/II study for ALL- MCL & CLL and has received FDA’s BT and EMA’s PRIME designation for r/r MCL with its anticipated PDUFA date as Aug 10- 2020

Click here ­to­ read full press release/ article | Ref: Gilead | Image: Kite Pharma