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

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

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

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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