BMS Receives FDA’s Priority Review Acceptance of Lisocabtagene Maraleucel’s BLA for Patients with Relapsed or Refractory Large B-Cell Lymphoma

BMS Receives FDA’s Priority Review Acceptance of Lisocabtagene Maraleucel’s BLA for Patients with Relapsed or Refractory Large B-Cell Lymphoma

Shots:

  • The BLA is based on P-I TRANSCEND NHL 001 study assessing Lisocabtagene Maraleucel (liso-cel) in 268 patients with r/r B-cell NHL including DLBCL, HGL, PMBCL and Grade 3B FL
  • The P-I TRANSCEND NHL 001 study is the largest study of CD19-directed CAR T cells supporting the BLA submission. Liso-cel has received FDA’s BT & RMAT designation for r/r large B-cell NHL and PRIME designation for r/r DLBCL
  • Liso-cel is CART-cell therapy targeting CD19 with a defined composition of CD8+ & CD4+ CAR T cells to treat r/r B-cell NHL prior treated with 2L+ therapies with its anticipated PDUFA date as Aug 17, 2020

Click here ­to­ read full press release/ article | Ref: BMS | Image: WSJ