Shots:

• The accelerated approval follows FDA’s PR and BT designation and is based on ZUMA-2 study assessing Tecartus (formerly KTE-X19) in 74 patients with r/r MCL prior treated with  anthracycline/ bendamustine-containing CT- an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib)
• Results: 87% patients responded to Tecartus (single infusion)- including 62 % patients achieved CR- 18% experienced Grade 3 or higher CRS and 37% experienced Grade 3 or higher neurologic toxicities
• Tecartus is an autologous- anti-CD19 CAR T cell therapy- currently under EC review and has received EMA’s PRIME designation for r/r MCL. The therapy will be manufactured in Kite’s commercial manufacturing facility in El Segundo- California

  Ref: Kite | Image:  Stat News