Kite’s KTE-X19 Receives the US FDA’s Priority Review for Relapsed or Refractory Mantle Cell Lymphoma

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