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
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